Duricef

NDA 50512, held by Warner Chilcott. Cefadroxil/Cefadroxil Hemihydrate.

As of Nov 13, 2026, NDA 50512 (Duricef), held by Warner Chilcott, was first approved by FDA on Feb 17, 1978, with 36 approved supplements and 0 published complete response letters.

First approved: Feb 17, 1978
Review: Standard
Supplements approved: 36
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below

Date	Submission	Status	Documents
Aug 30, 1991	Supplement 11Efficacy (new indication or use)	Approved	None posted
Feb 17, 1978	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
DuricefEQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Cefadroxil/Cefadroxil Hemihydrate	DiscontinuedReference drug
DuricefEQ 250MG BASE · capsule;oral	Cefadroxil/Cefadroxil Hemihydrate	Discontinued

All 37 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 5, 2007	Supplement 46Labeling · Standard review	Approved	Letter Label
Dec 16, 2003	Supplement 45Labeling · Standard review	Approved	Label Letter
May 3, 2002	Supplement 44Labeling · Standard review	Approved	Letter Label
Oct 15, 1996	Supplement 43Labeling · Standard review	Approved	None posted
Dec 5, 1995	Supplement 42Labeling · Standard review	Approved	None posted
Aug 30, 1991	Supplement 11Efficacy (new indication or use)	Approved	None posted
May 18, 1989	Supplement 13Labeling	Approved	None posted
Sep 12, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 18, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 12, 1986	Supplement 7Labeling	Approved	None posted
Jul 8, 1983	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 17, 1982	Supplement 5Manufacturing · Standard review	Approved	None posted
May 21, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 20, 1982	Supplement 40Labeling	Approved	None posted
Nov 2, 1981	Supplement 39Manufacturing · Standard review	Approved	None posted
Nov 2, 1981	Supplement 38Manufacturing · Standard review	Approved	None posted
Oct 27, 1981	Supplement 37Manufacturing · Standard review	Approved	None posted
Aug 24, 1981	Supplement 36Manufacturing · Standard review	Approved	None posted
Aug 18, 1981	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 21, 1981	Supplement 33Labeling	Approved	None posted
Apr 3, 1981	Supplement 32Labeling	Approved	None posted
May 5, 1980	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 22, 1980	Supplement 31Labeling	Approved	None posted
Jan 31, 1980	Supplement 30Labeling	Approved	None posted
Jan 24, 1980	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 21, 1980	Supplement 29Manufacturing · Standard review	Approved	None posted
Dec 28, 1979	Supplement 27Labeling	Approved	None posted
Nov 30, 1979	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 25, 1979	Supplement 25Labeling	Approved	None posted
Apr 26, 1979	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 26, 1979	Supplement 21Labeling	Approved	None posted
Aug 14, 1978	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 21, 1978	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 7, 1978	Supplement 18Manufacturing · Standard review	Approved	None posted
May 8, 1978	Supplement 17Labeling	Approved	None posted
May 8, 1978	Supplement 16Labeling	Approved	None posted
Feb 17, 1978	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50512
Drugs@FDA: Overview at FDA
Company: Warner Chilcott Company

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