Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!


Sanofi-Aventis U.S. LLC,; Withdrawal of Approval of 11 Abbreviated New Drug Applications

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of November 30, 2020.

Start Further Info


Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980,

End Further Info End Preamble Start Supplemental 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 § 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 § 314.150(c) is without prejudice to refiling.

Application No.DrugApplicant
ANDA 061884Rifamate (isoniazid and rifampin) Capsules, 150 milligrams (mg); 300 mgSanofi-Aventis U.S. LLC 55 Corporate Dr., Bridgewater, NJ 08807.
ANDA 065196Ceftazidime for Injection, 1 gram(g)/vialMorton Grove Pharmaceuticals Inc./Wockhardt USA LLC., 6451 Main St., Morton Grove, IL 60053.
ANDA 065197Cefotaxime for Injection, Equivalent to (EQ) 1 g base/vial; EQ 2 g base/vial; EQ 500 mg base/vialDo.
ANDA 078229Terbinafine Hydrochloride (HCl) Tablets, EQ 250 mg baseDo.
ANDA 081134Niacin Tablets, 500 mgDo.
ANDA 091659Heparin Sodium Injection, 5,000 units/milliliter (mL)CASI Pharmaceuticals, Inc., 9620 Medical Center Dr., Suite 300, Rockville, MD 20850.
ANDA 202647Granisetron HCl Injection, EQ 0.1 mg base/mL (EQ 0.1 mg base/mL)Yung Shin Pharmaceutical Industrial Co., Ltd./Carlsbad Technology, Inc., 5922 Farnsworth Ct., Carlsbad, CA 92008.
ANDA 202648Granisetron HCl Injection, EQ 1 mg base/mL (EQ 1 mg base/mL); EQ 4 mg base/4 mL (EQ 1 mg base/mL)Do.
ANDA 205173Bosentan Tablets, 62.5 mg and 125 mgMylan Pharmaceuticals Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504.
ANDA 207843Telmisartan Tablets, 20 mg, 40 mg, and 80 mgHisun Pharmaceutical (Hangzhou) Co., Ltd./Hisun Pharmaceuticals USA, Inc., 200 Crossing Blvd., 2nd Floor, Bridgewater, NJ 08807.
Start Printed Page 68889
ANDA 210681Ranitidine HCl Capsules, EQ 150 mg base and EQ 300 mg baseNovitium Pharma LLC, 70 Lake Dr., East Windsor, NJ 08520.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 30, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. 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 November 30, 2020 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.

Start Signature

Dated: October 26, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2020-24012 Filed 10-29-20; 8:45 am]