Miconazole Nitrate

ANDA 74030, held by Teva Pharms. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 74030 (Miconazole Nitrate), held by Teva Pharms, was first approved by FDA on Oct 30, 1992, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1992
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Oct 30, 1992	Original application	Approved	None posted

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements


Mar 23, 1999	Supplement 12Manufacturing	Approved	None posted
Jun 11, 1998	Supplement 11Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 10Manufacturing	Approved	None posted
May 31, 1996	Supplement 8Manufacturing	Approved	None posted
Jun 20, 1994	Supplement 7Labeling	Approved	None posted
Apr 11, 1994	Supplement 6Labeling	Approved	None posted
Nov 19, 1993	Supplement 1Manufacturing	Approved	None posted
Nov 5, 1993	Supplement 3Labeling	Approved	None posted
Nov 5, 1993	Supplement 5Manufacturing	Approved	None posted
Jul 21, 1993	Supplement 4Labeling	Approved	None posted
Feb 3, 1993	Supplement 2Labeling	Approved	None posted
Oct 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 74030
Drugs@FDA: Overview at FDA
Company: Teva 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