Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications
Federal Register, Volume 77 Issue 115 (Thursday, June 14, 2012)
Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)
Notices
Pages 35691-35698
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2012-14476
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2012-N-0517
Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing its intention to deem to be withdrawn any abbreviated new drug applications (ANDAs) that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since July 8, 1991. Each of these applications will be
Page 35692
deemed to have been withdrawn voluntarily by the applicant unless the applicant informs the Agency in writing that it intends to actively pursue approval of the application(s) (see DATES).
DATES: The applicant of an ANDA covered by this notice that intends to actively pursue approval of its application must submit a written notification to FDA by August 13, 2012.
ADDRESSES: Applicants should submit written notifications to the ANDA archival file to the Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Document Control Room, MPN7, 7620 Standish Pl., Rockville, MD 20855. A copy of written notifications should also be submitted to Thomas Hinchliffe, Center for Drug Evaluation and Research (HFD-617), Food and Drug Administration, 7500 Standish Pl., rm. N-142, MPN2, Rockville, MD 20855, FAX: 240-276-
8440, email: inactiveandas@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Thomas Hinchliffe, Center for Drug Evaluation and Research (HFD-617), Food and Drug Administration, 7500 Standish Pl., rm. N-142, MPN2, Rockville, MD 20855, 240-276-8433, FAX: 240-276-9310, email: inactiveandas@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
-
Background
FDA has identified 364 ANDAs for which FDA has not received any communication from the ANDA applicant since July 8, 1991, or earlier (Inactive ANDAs). (See section IV of this document for the list of Inactive ANDAs). For purposes of this document, the term ``applicant'' includes any successor in interest. FDA's regulations provide that the Agency will consider withdrawn any application for which the applicant has not contacted the Agency about its intention regarding such application within 1 year after issuance of a complete response letter to the applicant (see 21 CFR 314.110(c)). The Inactive ANDAs, however, predate, and consequently are not subject to this regulation. Therefore, the Inactive ANDAs have not been deemed withdrawn although there has been no communication from the applicants since July 8, 1991, or earlier.
-
Withdrawal of Inactive ANDAs
At this time, the Agency is announcing its intention to deem all Inactive ANDAs to have been voluntarily withdrawn by the respective applicants as of August 13, 2012, unless the applicant informs the Agency in writing by the date set forth under DATES in this document of its intent to actively pursue approval of the application. Therefore, in the absence of a written notice with respect to an Inactive ANDA by the date specified in this notice, the ANDA will be considered to have been withdrawn by the applicant. No further notice of the withdrawal of Inactive ANDAs will be provided. Withdrawal of an unapproved application is without prejudice to resubmission of that application (21 CFR 314.65). Because of the length of time that has passed since these applications were submitted, FDA strongly recommends that any applicant intending to actively pursue approval review the application carefully to determine whether it satisfies current ANDA requirements (21 CFR part 314).
-
Action by the Applicant
If the applicant wishes to actively pursue approval of an Inactive ANDA and does not wish the application to be deemed by FDA to have been voluntarily withdrawn, the applicant must inform the Agency in writing within the time specified in this document. Written notice should be provided to Thomas Hinchliffe and the Office of Generic Drugs (see ADDRESSES).
FDA also asks any applicant that agrees to consider its application to be voluntarily withdrawn to send a written notice to Thomas Hinchliffe and the Office of Generic Drugs (see ADDRESSES) to confirm that agreement. However, applicants of Inactive ANDAs covered by this notice who wish their applications to be withdrawn are not required to provide written notice to FDA.
-
Details About Inactive ANDAs
Information about the Inactive ANDAs is listed in this section of the document. To protect applicant confidentiality, this notice lists the application number and drug name for each Inactive ANDA and separately lists the name of the applicant as shown in the information on file with FDA, without linking identified applicants with specific applications or drug names. In some cases, the identified applicants may no longer exist as ongoing business entities. If an identified applicant is unsure which application(s) belong to it (if any), it may contact Thomas Hinchliffe (see FOR FURTHER INFORMATION CONTACT).
Alphabetical List of Abbreviated New Drug Application Applicants
1st Texas Pharmaceuticals, Inc., Subsidiary of Scherer Laboratories Inc.
Abraxis Pharmaceutical Products
AH Robins, Co.
Alpharma US Pharmaceuticals Division
Ambix Laboratories Division of Organics Corp America
Ankerfarm SpA
Ankerman SpA
Antibioticos SA
Arcum Pharmaceutical Corp.
Banner Pharmacaps, Inc.
Barr Laboratories, Inc.
Baxter Healthcare Corp.
Beecham Laboratories Division of Beecham Inc.
Beecham SA
Bel Mar Laboratories, Inc.
Biocraft Laboratories, Inc.
Biometric Testing, Inc.
Boots Laboratories, Inc., Division of Boots Pharmaceuticals Inc.
Bristol Laboratories, Inc., Division of Bristol Myers Co.
Bristol Myers Co. International Division
Bristol Myers Industrial Division
Bristol Myers Squibb
Camall Co., Inc.
Carlo Erba SpA
Century Pharmaceuticals, Inc.
Chemibiotic Ireland, Ltd.
Chromalloy Laboratories Division of Chromalloy Pharmaceuticals, Inc.
Clifford Chemical Corp.
CM Bundy Co.
Comatic Laboratories, Inc.
Credo Co.
Delco Chemical Co., Inc.
Dell Laboratories, Inc.
Dermasave Laboratories, Inc.
Dista Products Co. Division of Eli Lilly & Co.
DM Pharmaceuticals, Inc.
Dorasol Laboratories
Dunhall Pharmaceuticals, Inc.
ER Squibb and Sons Pharmaceutical Laboratories
Ersana, Inc., Subsidiary of ER Squibb and Sons
Everylife
Fallek Products Co., Inc.
Farmila Farmaceutica
Faton Pharmaceuticals, Inc.
Fermion Oy
Ferndale Laboratories, Inc.
Fisons Corp.
Forest Laboratories, Inc.
Forest Pharmaceuticals, Inc.
Forrest Laboratories, Inc.
G & W Co.
Glenwood Laboratories, Inc.
Global Pharmaceutical Corp.
Gruppo Lepetit SpA Subsidiary of Merrell Dow Pharmaceuticals, Inc.
Heather Drug Co., Inc.
Herald Pharmacal, Inc.
Hoffmann La Roche, Inc.
ICI Ltd.
Ingram Pharmaceutical Co.
Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc.
Page 35693
ISF
Kasar Laboratories Division of Kasar Co.
Kasco EFCO Laboratories, Inc., Division of Byk Gulden, Inc.
KV Pharmaceutical, Co.
Lannett Co, Inc.
Lederle Laboratories Division of American Cyanamid Co.
Leiner Health Products, Inc.
Lemmon Co. Subsidiary of Tag Pharmaceutical, Inc.
Life Laboratories, Inc.
Linden Laboratories, Inc., Subsidiary of Chromalloy American Corp.
Luitpold Pharmaceuticals, Inc.
Marshall Pharmacal Corp.
MD Pharmaceutical, Inc.
Medev, Inc.
Mission Pharmacal Co.
M M Mast & Co.
Mutual Pharmaceutical Company, Inc.
Newtron Pharmaceuticals, Inc.
Novartis Pharmaceuticals Corp.
Nylos Trading Co., Inc.
Panray Corp Subsidiary of Ormont Drug and Chemical Co., Inc.
Parke Davis Division of Warner Lambert Co.
Pasadena Research Laboratories, Inc.
Penick Corp.
Person and Covey, Inc.
Pfizer Co.
Pfizer, Inc.
Pharmaceutical Associates, Inc.
Pharmacia and Upjohn Co.
Pharmadyne Laboratories, Inc.
Pharmavite Pharmaceuticals
Phoenix Laboratories, Inc.
Polfa Pharmaceutical Works
Premo Pharmaceutical Laboratories, Inc.
Purepac Pharmaceutical Co.
Rachelle Laboratories Italia SpA
Reed and Carnrick Division of Block Drug Co., Inc.
Rexar Pharmacal
Richlyn Laboratories, Inc.
Robinson Laboratories, Inc.
Roussel Corp.
Rovers Pharmacal, Inc.
RP Scherer Corp.
Sandoz, Inc.
Scherer Laboratories, Inc.
Schering Corp. Subsidiary of Schering Plough Corp.
Smith Kline and French Laboratory Co. Subsidiary of SmithKline Beckman
Societa Italiana Prodotti Schering
Sperti Drug Products, Inc.
Stayner Corp.
Steri Med, Inc. Subsidiary of Ketchum Laboratories, Inc.
Tablicaps, Inc.
Tera Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
Titan Pharmacal, Co.
Travenol Laboratories, Inc.
Valeant Pharmaceuticals International
Watson Laboratories, Inc.
Western Research Laboratories, Inc.
West-Ward Pharmaceutical Corp.
Wharton Laboratories, Inc., Division of US Ethicals
Whiteworth Towne Paulsen, Inc.
Wyeth Ayerst Laboratories
Zenith Laboratories, Inc.
Table 1--Abbreviated New Drug Application (ANDA) Numbers With Product
Names
------------------------------------------------------------------------
ANDA No. Product name
------------------------------------------------------------------------
60881............................................. Tetracycline
hydrochloride.
60913............................................. Dicloxacillin
sodium.
60919............................................. Neomycin sulfate;
bacitracin.
60965............................................. Neomycin sulfate;
polymyxin b
sulfates;
bacitracin.
61046............................................. Penicillin g sodium.
61091............................................. Phenethicillin
potassium.
61093............................................. Penicillin g
potassium.
61097............................................. Troleandomycin.
61099............................................. Doxycycline hyclate.
61102............................................. Oxytetracycline
calcium.
61114............................................. Chlortetracycline
hydrochloride.
61116............................................. Ampicillin
trihydrate.
61117............................................. Phenethicillin
potassium.
61118............................................. Cloxacillin sodium.
61119............................................. Dicloxacillin
sodium.
61120............................................. Tetracycline.
61121............................................. Tetracycline
phosphate.
61142............................................. Penicillin g
potassium.
61144............................................. Amphotericin b.
61145............................................. Penicillin g
potassium.
61152............................................. Tetracycline
hydrochloride.
61170............................................. Bacitracin.
61171............................................. Bacitracin zinc.
61191............................................. Tetracycline
hydrochloride.
61192............................................. Tetracycline
hydrochloride.
61194............................................. Paromomycin sulfate.
61197............................................. Tetracycline
hydrochloride.
61382............................................. Ampicillin
trihydrate.
61420............................................. Tetracycline.
61422............................................. Oxytetracycline
hydrochloride.
61423............................................. Oxytetracycline.
61428............................................. Chloramphenicol
palmitate.
61429............................................. Tetracycline.
61430............................................. Chloramphenicol.
61431............................................. Chloramphenicol.
61432............................................. Chloramphenicol
sodium succinate.
61433............................................. Chloramphenicol
sodium succinate.
61440............................................. Tetracycline
hydrochloride.
61442............................................. Erythromycin
estolate.
61556............................................. Tetracycline.
61564............................................. Methacycline
hydrochloride.
61565............................................. Paromomycin sulfate.
61570............................................. Hetacillin.
Page 35694
61581............................................. Tetracycline
hydrochloride.
61582............................................. Tetracycline.
61597............................................. Ampicillin
trihydrate.
61604............................................. Ampicillin sodium.
61608............................................. Tetracycline
hydrochloride.
61629............................................. Penicillin g
benzathine.
61630............................................. Streptomycin
sulfate.
61631............................................. Dihydrostreptomycin
sulfate.
61749............................................. Dicloxacillin
sodium.
61750............................................. Ampicillin
trihydrate.
61751............................................. Doxycycline hyclate.
61754............................................. Griseofulvin.
61775............................................. Tetracycline.
61777............................................. Mitomycin.
61778............................................. Erythromycin.
61779............................................. Erythromycin
stearate.
61784............................................. Tetracycline
hydrochloride.
61795............................................. Oxacillin sodium.
61796............................................. Oxacillin sodium.
61797............................................. Methicillin sodium.
61804............................................. Carbenicillin
indanyl sodium.
61824............................................. Tetracycline.
61825............................................. Tetracycline.
61843............................................. Penicillin v
potassium.
61844............................................. Ampicillin.
61845............................................. Ampicillin
trihydrate.
61852............................................. Tetracycline
phosphate complex.
61993............................................. Cloxacillin sodium.
62016............................................. Amoxicillin
trihydrate.
62019............................................. Tetracycline
hydrochloride.
62020............................................. Tetracycline
phosphate.
62344............................................. Cloxacillin sodium.
80004............................................. Propylthiouracil.
80088............................................. Sulfadiazine.
80200............................................. Succinylcholine
chloride.
80313............................................. Methyltestosterone.
80350............................................. Prednisone.
80351............................................. Prednisolone.
80359............................................. Prednisone.
80452............................................. Hydrocortisone.
80456............................................. Hydrocortisone.
80501............................................. Diphenhydramine
hydrochloride.
80559............................................. Cyanocobalamin.
80560............................................. Pyridoxine
hydrochloride.
80561............................................. Thiamine
hydrochloride.
80616............................................. Cyanocobalamin.
80676............................................. Testosterone
propionate.
80840............................................. Propylthiouracil.
80943............................................. Vitamin a palmitate.
80947............................................. Aminosalicylate
sodium.
80956............................................. Vitamin d.
80985............................................. Vitamin a.
83002............................................. Diethylstilbestrol.
83003............................................. Diethylstilbestrol.
83004............................................. Diethylstilbestrol.
83005............................................. Diethylstilbestrol.
83006............................................. Diethylstilbestrol.
83007............................................. Diethylstilbestrol.
83114............................................. Vitamin a palmitate.
83133............................................. Folic acid.
83134............................................. Vitamin a.
83197............................................. Propoxyphene
hydrochloride.
83203............................................. Niacin.
83208............................................. Cortisone acetate.
83233............................................. Hydrocortisone
acetate.
83243............................................. Chlorpheniramine
maleate.
83258............................................. Butabarbital sodium.
83259............................................. Pentobarbital
sodium.
83268............................................. Butabarbital sodium.
83269............................................. Butabarbital sodium.
83293............................................. Propoxyphene
hydrochloride.
83311............................................. Vitamin a palmitate.
Page 35695
83321............................................. Vitamin a palmitate.
83335............................................. Prednisolone
acetate.
83343............................................. Meprobamate.
83374............................................. Estrogens,
esterified.
83394............................................. Chlorpheniramine
maleate.
83421............................................. Probenecid.
83439............................................. Quinidine sulfate.
83444............................................. Rauwolfia
serpentina.
83454............................................. Lidocaine.
83494............................................. Meprobamate.
83503............................................. Negatol.
83537............................................. Secobarbital sodium.
83553............................................. Procainamide
hydrochloride.
83562............................................. Prednisolone
acetate.
83578............................................. Butabarbital sodium.
83674............................................. Diphenhydramine
hydrochloride.
83675............................................. Prednisolone.
83676............................................. Prednisone.
83756............................................. Piperazine citrate.
83772............................................. Pyridoxine
hydrochloride.
83864............................................. Secobarbital sodium.
83865............................................. Promethazine
hydrochloride.
83867............................................. Rauwolfia
serpentina.
83880............................................. Propoxyphene
hydrochloride.
83912............................................. Vitamin a palmitate.
83926............................................. Ergotamine tartrate;
caffeine.
83929............................................. Cortisone acetate.
83940............................................. Diethylstilbestrol.
83958............................................. Propylthiouracil.
83960............................................. Prednisolone.
83974............................................. Trihexyphenidyl
hydrochloride.
84008............................................. Chlorpheniramine
maleate.
84009............................................. Prednisone.
84016............................................. Dextroamphetamine
hydrochloride.
84027............................................. Promethazine
hydrochloride.
84073............................................. Benzthiazide.
84080............................................. Promethazine
hydrochloride.
84097............................................. Dicyclomine
hydrochloride.
84237............................................. Niacin.
84257............................................. Dicyclomine
hydrochloride.
84262............................................. Phenylbutazone.
84263............................................. Dimenhydrinate.
84293............................................. Dicyclomine
hydrochloride.
84298............................................. Hydrochlorothiazide.
84311............................................. Phenylbutazone.
84365............................................. Dexamethasone sodium
phosphate.
84382............................................. Meclizine
hydrochloride.
84410............................................. Trichlormethiazide.
84428............................................. Propantheline
bromide.
84459............................................. Propylthiouracil.
84485............................................. Phentermine
hydrochloride.
84552............................................. Aminophylline.
84559............................................. Theophylline.
84632............................................. Aminophylline.
84670............................................. Chlordiazepoxide.
84671............................................. Chlordiazepoxide.
84672............................................. Chlordiazepoxide.
84695............................................. Phentermine
hydrochloride.
84736............................................. Rescinnamine.
84846............................................. Methocarbamol.
84856............................................. Cortisone acetate.
84871............................................. Prednisolone
acetate.
84906............................................. Reserpine;
hydrochlorothiazide
.
84979............................................. Hydrocortisone.
85033............................................. Methocarbamol.
85115............................................. Prednisone.
85170............................................. Prednisolone.
85174............................................. Cortisone acetate.
85185............................................. Diethylpropion
hydrochloride.
85207............................................. Reserpine.
85242............................................. Chlordiazepoxide
hydrochloride.
85258............................................. Chlordiazepoxide.
Page 35696
85259............................................. Chlordiazepoxide.
85270............................................. Methyltestosterone.
85280............................................. Chlordiazepoxide
hydrochloride.
85281............................................. Chlordiazepoxide
hydrochloride.
85308............................................. Phenytoin sodium.
85325............................................. Methylprednisolone.
85360............................................. Chlordiazepoxide
hydrochloride.
85405............................................. Perphenazine.
85412............................................. Tripelennamine
hydrochloride.
85419............................................. Quinidine sulfate.
85439............................................. Butalbital; aspirin;
phenacetin;
caffeine.
85442............................................. Chlordiazepoxide
hydrochloride.
85489............................................. Probenecid.
85516............................................. Theophylline.
85576............................................. Estradiol.
85590............................................. Oxyphenbutazone.
85592............................................. Brompheniramine
maleate.
85613............................................. Phendimetrazine
tartrate.
85647............................................. Amitriptyline
hydrochloride.
85649............................................. Amitriptyline
hydrochloride.
85678............................................. Amitriptyline
hydrochloride.
85680............................................. Amitriptyline
hydrochloride.
85696............................................. Isoniazid;
pyridoxine
hydrochloride.
85707............................................. Isopropamide iodide.
85716............................................. Hydralazine
hydrochloride.
85717............................................. Hydralazine
hydrochloride.
85725............................................. Phendimetrazine
tartrate.
85730............................................. Cyanocobalamin.
85731............................................. Phentermine
hydrochloride.
85760............................................. Chlorothiazide.
85774............................................. Methyltestosterone.
85776............................................. Methyltestosterone.
85806............................................. Reserpine;
hydralazine
hydrochloride;
hydrochlorotiazide.
85807............................................. Meclizine
hydrochloride.
85808............................................. Meclizine
hydrochloride.
85812............................................. Propoxyphene
hydrochloride.
85901............................................. Imipramine
hydrochloride.
85918............................................. Ergotamine tartrate;
caffeine.
85942............................................. Amitriptyline
hydrochloride.
85943............................................. Triamcinolone
acetonide.
85946............................................. Amitriptyline
hydrochloride.
85947............................................. Amitriptyline
hydrochloride.
85948............................................. Amitriptyline
hydrochloride.
85949............................................. Amitriptyline
hydrochloride.
85950............................................. Amitriptyline
hydrochloride.
85954............................................. Methyltestosterone.
85955............................................. Methyltestosterone.
85972............................................. Acetaminophen;
salicylamide;
caffeine; codeine
phosphate.
86068............................................. Triamcinolone
acetonide.
86111............................................. Amodiaquine
hydrochloride.
86115............................................. Bethanechol
chloride.
86125............................................. Quinidine sulfate.
86128............................................. Chlorpromazine.
86131............................................. Acetazolamide.
86207............................................. Hydrocortisone
acetate.
86211............................................. Phendimetrazine
tartrate.
86253............................................. Trihexyphenidyl
hydrochloride.
86254............................................. Chlorothiazide.
86279............................................. Hydrochlorothiazide.
86286............................................. Butalbital; aspirin;
phenacetin;
caffeine.
86288............................................. Amitriptyline
hydrochloride.
86316............................................. Orphenadrine
citrate.
86317............................................. Diphenoxylate
hydrochloride;
atropine sulfate.
86318............................................. Hydrochlorothiazide.
86319............................................. Hydrochlorothiazide.
86320............................................. Methocarbamol.
86321............................................. Methocarbamol.
86322............................................. Prednisone.
86324............................................. Prednisone.
86326............................................. Butalbital; aspirin;
phenacetin;
caffeine.
86327............................................. Trifluoperazine
hydrochloride.
86334............................................. Hydrocortisone.
Page 35697
86343............................................. Thioridazine
hydrochloride.
86345............................................. Thioridazine
hydrochloride.
86354............................................. Thioridazine
hydrochloride.
86377............................................. Hydrochlorothiazide.
86400............................................. Hydrocortisone
acetate.
86401............................................. Hydrocortisone
acetate.
86404............................................. Phendimetrazine
tartrate.
86407............................................. Phendimetrazine
tartrate.
86411............................................. Dimenhydrinate.
86412............................................. Dicyclomine
hydrochloride.
86430............................................. Phendimetrazine;adip
ic acid.
86431............................................. Phendimetrazine.
86436............................................. Homatropine
methylbromide.
86437............................................. Homatropine
hydrobromide.
86438............................................. Trifluoperazine
hydrochloride.
86443............................................. Trifluoperazine
hydrochloride.
86447............................................. Trifluoperazine
hydrochloride.
86476............................................. Diazepam.
86510............................................. Phentermine
hydrochloride.
86515............................................. Phentermine
hydrochloride.
86529............................................. Dicyclomine
hydrochloride;
phenobarbital.
86555............................................. Phendimetrazine
tartrate.
86563............................................. Dicyclomine
hydrochloride;
phenobarbital.
86564............................................. Phenobarbital;
atropine sulfate;
hyoscyamine
sulfate; hyscyamine
hydrobromide.
86565............................................. Phenobarbital;
hyoscyamine
sulfate; atropine
sulfate;
scopolamine
hydrobromide.
86566............................................. Dicyclomine
hydrochloride;
phenobarbital.
86581............................................. Chlordiazepoxide
hydrochloride;
clidinium bromide.
86591............................................. Phenobarbital;
hyoscyamine
sulfate; atropine
sulfate;
scopolamine
hydrobromide.
86625............................................. Dicyclomine
hydrochloride.
86627............................................. Meprobamate;
tridihexethyl
chloride.
86629............................................. Meprobamate;
tridihexethyl
chloride.
86630............................................. Piperidolate
hydrochloride;
phenobarbital.
86634............................................. Chlordiazepoxide
hydrochloride;
clidinium bromide.
86644............................................. Piperidolate
hydrochloride.
86647............................................. Chlordiazepoxide
hydrochloride;
clidinium bromide.
86650............................................. Anisotropine
methylbromide;
phenobarbital.
86654............................................. Meprobamate;
tridihexethyl
chloride.
86655............................................. Atropine sulfate;
hyoscyamine
sulfate;
phenobarbital;
scopolamine
hydrobromide.
86657............................................. Phenobarbital;
atropine sulfate;
hyoscyamine
sulfate;
scopolamine
hydrobromide.
86658............................................. Meprobamate;
tridihexethyl
chloride.
86665............................................. Phenobarbital;
atropine sulfate;
hyoscyamine
sulfate;
scopolamine
hydrobromide.
86667............................................. Chlordiazepoxide
hydrochloride;
clidinium bromide.
86668............................................. Phenobarbital;
belladonna alkaloid
malates, l-.
86669............................................. Dicyclomine
hydrochloride.
86670............................................. Atropine sulfate;
hyoscyamine
sulfate;
phenobarbital;
scopolamine
hydrobromide.
86671............................................. Phenobarbital;
hyoscyamine
sulfate.
86674............................................. Meprobamate;
tridihexethyl
chloride.
86675............................................. Butabarbital sodium;
simethicone;
atropine sulfate;
hyoscyamine
sulfate;
scopoamine.
86685............................................. Chlordiazepoxide
hydrochloride;
clidinium bromide.
86687............................................. Phenobarbital;
belladonna extract.
86692............................................. Amobarbital;
belladonna.
86694............................................. Oxyphencyclimine
hydrochloride;
phenobarbital.
86696............................................. Phenobarbital;
hyoscyamine
sulfate; atropine
sulfate;
scopolamine
hydrobromide.
86701............................................. Atropine sulfate;
phenobarbital.
86703............................................. Phenobarbital;
hyoscyamine
sulfate; atropine
sulfate;
scopolamine
hydrobromide.
86704............................................. Phenobarbital;
hyoscyamine
sulfate; atropine
sulfate;
scopolamine
hydrobromide.
86706............................................. Meprobamate;
tridihexethyl
chloride.
86708............................................. Cyproheptadine
hydrochloride.
86709............................................. Meprobamate;
tridihexethyl
chloride.
86721............................................. Procainamide
hydrochloride.
86770............................................. Nitroglycerin.
86773............................................. Triamcinolone
diacetate.
86774............................................. Erythrityl
tetranitrate.
86775............................................. Isosorbide
dinitrate.
86776............................................. Pentaerythritol
tetranitrate.
86777............................................. Nitroglycerin.
86779............................................. Nitroglycerin.
86782............................................. Nitroglycerin.
86783............................................. Isosorbide
dinitrate.
86784............................................. Pentaerythritol
tetranitrate.
86785............................................. Pentaerythritol
tetranitrate.
86786............................................. Isosorbide
dinitrate.
Page 35698
86789............................................. Estradiol valerate.
86794............................................. Dipyridamole.
86799............................................. Atropine sulfate;
phenobarbital.
86838............................................. Pentaerythritol
tetranitrate.
86839............................................. Isosorbide
dinitrate.
86868............................................. Chlorpromazine
hydrochloride.
86882............................................. Hydrocortisone.
86897............................................. Phenobarbital;
hyoscyamine
hydrobromide;
atropine sulfate;
scopolamine
hydrobromide.
86921............................................. Chlordiazepoxide
hydrochloride;
clidinum bromide.
86970............................................. Aminophylline.
86976............................................. Doxylamine
succinate;
pyridoxine
hydrochloride.
86991............................................. Probenecid.
86999............................................. Butalbital; aspirin;
phenacetin;
caffeine.
87000............................................. Hydralazine
hydrochloride.
87041............................................. Phendimetrazine
tartrate.
87064............................................. Piperazine citrate.
87069............................................. Sulfisoxazole
acetyl.
87096............................................. Phentermine
hydrochloride.
87097............................................. Phentermine
hydrochloride.
87098............................................. Phentermine
hydrochloride.
87099............................................. Phentermine
hydrochloride.
87106............................................. Ergotamine tartrate;
caffeine.
87112............................................. Spironolactone.
87116............................................. Reserpine;
chlorothiazide.
87123............................................. Benzthiazide.
87124............................................. Benzthiazide.
87125............................................. Diphenhydramine
hydrochloride.
87134............................................. Promethazine
hydrochloride.
87166............................................. Phentolamine
hydrochloride.
87172............................................. Theophylline.
87198............................................. Belladonna alkaloid
malates, l-;
phenobarbital.
87379............................................. Quinidine gluconate.
87443............................................. Homatropine
methylbromide;
phenobarbital.
------------------------------------------------------------------------
Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
FR Doc. 2012-14476 Filed 6-13-12; 8:45 am
BILLING CODE 4160-01-P
