Miconazole Nitrate

ANDA 74366, held by Cosette Pharms Nc. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 74366 (Miconazole Nitrate), held by Cosette Pharms Nc, was first approved by FDA on Feb 22, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 22, 1996
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 22, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miconazole Nitrate2% · cream;vaginal	Miconazole Nitrate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jul 22, 2013	Supplement 9Labeling	Approved	None posted
Dec 13, 2002	Supplement 4Manufacturing	Approved	None posted
Aug 14, 2001	Supplement 3Manufacturing	Approved	None posted
May 24, 2000	Supplement 2Manufacturing	Approved	None posted
Mar 25, 1997	Supplement 1Manufacturing	Approved	None posted
Feb 22, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74366
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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