Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications


Federal Register, Volume 83 Issue 218 (Friday, November 9, 2018)

Federal Register Volume 83, Number 218 (Friday, November 9, 2018)


Pages 56086-56087

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2018-24605



Food and Drug Administration

Docket No. FDA-2018-N-4099

Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of December 10, 2018.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, email protected.

SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling.

Page 56087


Application No. Drug Applicant


ANDA 040747................. Benzphetamine Tedor Pharma, Inc.,

Hydrochloride (HCl) 400 Highland

Tablets, 25 Corporate Dr.,

milligrams (mg) and Cumberland, RI

50 mg. 02864.

ANDA 062356................. Gentamicin Sulfate Fresenius Kabi USA,

Injection USP, LLC, Three

Equivalent to (EQ) Corporate Dr., Lake

10 mg base/ Zurich, IL 60047.

milliliter (mL) and

EQ 40 mg base/mL.

ANDA 074097................. Isoflurane USP, Hospira, Inc., 275

99.9%. North Field Dr.,

Bldg. H1, Lake

Forest, IL 60045.

ANDA 076484................. Ciprofloxacin Fresenius Kabi USA,

Injection USP, 200 LLC.

mg/20 mL and 400 mg/

40 mL.

ANDA 080504................. Epinephrine and Belmora LLC, 2231

Lidocaine HCl Crystal Dr., #1000,

Injection, 0.01 mg/ Arlington, VA

mL; 2% and 0.02 mg/ 22202.

mL; 2%.

Lidocaine HCl

Injection, 2%..

ANDA 083559................. Mepivacaine HCl Do.

Injection, 3%.

ANDA 084315................. Dexamethasone Watson Laboratories,

Acetate Injectable Inc., Subsidiary of

Suspension USP, EQ Teva

8 mg base/mL. Pharmaceuticals

USA, Inc., 425

Privet Rd.,

Horsham, PA 19044.

ANDA 084850................. Levonordefrin and Belmora LLC.

Mepivacaine HCl

Injection, 2%; 0.05


ANDA 086389................. Lidocaine HCl International

Viscous Oral Medication Systems,

Topical Solution Ltd., 1886 Santa

USP, 2%. Anita Ave., South

El Monte, CA 91733.

ANDA 087863................. Choledyl SA Warner Chilcott Co.,

(oxtriphylline) LLC, Subsidiary of

Extended-Release Teva

Tablets USP, 400 mg. Pharmaceuticals

USA, Inc., 425

Privet Rd.,

Horsham, PA 19044.


Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 10, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on December 10, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

Dated: November 6, 2018.

Leslie Kux,

Associate Commissioner for Policy.

FR Doc. 2018-24605 Filed 11-8-18; 8:45 am