Cefprozil

ANDA 65267, held by Orchid Hlthcare. Cefprozil.

As of Nov 13, 2026, ANDA 65267 (Cefprozil), held by Orchid Hlthcare, was first approved by FDA on Dec 19, 2005, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2005
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 19, 2005	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Cefprozil250MG · tablet;oral	Cefprozil	Discontinued
Cefprozil500MG · tablet;oral	Cefprozil	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 9, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Jun 3, 2008	Supplement 1Labeling	Approved	None posted
Dec 19, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65267
Drugs@FDA: Overview at FDA
Company: Orchid Healthcare

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