Miconazole Nitrate

ANDA 74414, held by Cosette Pharms Nc. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 74414 (Miconazole Nitrate), held by Cosette Pharms Nc, was first approved by FDA on Apr 30, 1997, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1997
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Apr 30, 1997	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miconazole Nitrate100MG · suppository;vaginal	Miconazole Nitrate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 4, 2002	Supplement 3Manufacturing	Approved	None posted
May 31, 2002	Supplement 2Manufacturing	Approved	None posted
Oct 21, 1997	Supplement 1Manufacturing	Approved	None posted
Apr 30, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74414
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