Skip to Content

Notice

Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28 Abbreviated New Drug Applications

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from Regulations.gov 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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 28 abbreviated new drug applications held by Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), U.S. Agent for Sun Pharmaceutical Industries Limited, 270 Prospect Plains Rd., Cranbury, NJ 08512. The drug products are no longer marketed, and Sun Pharmaceutical has requested that the approval of the applications be withdrawn.

DATES:

January 19, 2017.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The applications listed in the table in this document are no longer marketed, and Sun Pharmaceutical has requested that FDA withdraw approval of the applications. The company has also, by its request, waived its opportunity for a hearing.

Application No.Drug
065007Cephalexin Capsules USP, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base.
065016Amoxicillin Capsules USP, 250 mg and 500 mg.
065021Amoxicillin Tablets USP (Chewable), 125 mg and 250 mg.
065059Amoxicillin Tablets USP, 500 mg and 875 mg.
065060Amoxicillin Tablets USP (Chewable), 200 mg and 400 mg.
065081Cephalexin for Oral Suspension USP, EQ 125 mg base/5 milliliters (mL) and EQ 250 mg base/5 mL.
065082Cefpodoxime Proxetil for Oral Suspension USP, EQ 50 mg base/5 mL and EQ 100 mg base/5 mL.
065083Cefpodoxime Proxetil Tablets USP, EQ 100 mg base and EQ 200 mg base.
Start Printed Page 92822
065102Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/EQ 125 mg base.
065109Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/EQ 125 mg base.
065113Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL.
065115Cefadroxil for Oral Suspension USP, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL.
065118Cefuroxime Axetil Tablets USP, EQ 125 mg base, EQ 250 mg base, and EQ 500 mg base.
065132Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/EQ 28.5 mg base per 5 mL and 400 mg/EQ 57 mg base per 5 mL.
065161Amoxicillin and Clavulanate Potassium Tablets USP (Chewable), 200 mg/EQ 28.5 mg base and 400 mg/EQ 57 mg base.
065207Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/EQ 42.9 mg base per 5 mL.
065323Cefuroxime Axetil for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL.
074975Acyclovir Capsules USP, 200 mg.
074980Acyclovir Tablets USP, 400 mg and 800 mg.
075132Ranitidine Tablets USP, EQ 75 mg base.
075439Ranitidine Tablets USP, EQ 150 mg base and EQ 300 mg base.
076041Sotret (isotretinoin) Capsules USP, 10 mg, 20 mg, and 40 mg.
076285Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg.
076332Fluconazole for Oral Suspension, 10 mg/mL and 40 mg/mL.
076409Nefazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg.
076503Sotret (isotretinoin) Capsules USP, 30 mg.
076606Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg.
076739Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mg.

Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective January 19, 2017.

Start Signature

Dated: December 15, 2016.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2016-30623 Filed 12-19-16; 8:45 am]

BILLING CODE 4164-01-P