Cefzil

NDA 50664, held by Corden Pharma. Cefprozil.

As of Nov 14, 2026, NDA 50664 (Cefzil), held by Corden Pharma, was first approved by FDA on Dec 23, 1991, with 23 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1991
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below


Sep 5, 1996	Supplement 14Efficacy (new indication or use) · Standard review	Approved	None posted
May 17, 1995	Supplement 4Efficacy (new indication or use)	Approved	None posted
Dec 31, 1992	Supplement 2Efficacy (new indication or use)	Approved	None posted
Dec 23, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Cefzil250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cefprozil	DiscontinuedReference drug
Cefzil500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cefprozil	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Nov 22, 2016	Supplement 26Labeling · Standard review	Approved	Label Letter
Sep 14, 2007	Supplement 24Labeling · Standard review	Approved	Letter Label
Jun 23, 2004	Supplement 23Labeling · Standard review	Approved	Letter Label
Oct 1, 2001	Supplement 20Labeling · Standard review	Approved	None posted
Apr 19, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 10, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 18, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 6, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 26, 1997	Supplement 15Labeling · Standard review	Approved	None posted
May 29, 1997	Supplement 17Labeling · Standard review	Approved	None posted
Apr 23, 1997	Supplement 16Labeling · Standard review	Approved	None posted
Sep 5, 1996	Supplement 14Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 26, 1995	Supplement 13Labeling · Standard review	Approved	None posted
Aug 31, 1995	Supplement 6Labeling · Standard review	Approved	None posted
Aug 31, 1995	Supplement 7Labeling · Standard review	Approved	None posted
May 17, 1995	Supplement 4Efficacy (new indication or use)	Approved	None posted
Apr 10, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 8, 1995	Supplement 11Labeling · Standard review	Approved	None posted
Nov 10, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 6, 1994	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 21, 1994	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 23, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 31, 1992	Supplement 2Efficacy (new indication or use)	Approved	None posted
Dec 23, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50664
Drugs@FDA: Overview at FDA
Company: Corden Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters