Miconazole Nitrate

ANDA 74136, held by Teva. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 74136 (Miconazole Nitrate), held by Teva, was first approved by FDA on Jan 4, 1995, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 4, 1995
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 4, 1995	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 9Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 8Manufacturing	Approved	None posted
Aug 1, 1996	Supplement 7Manufacturing	Approved	None posted
Jun 13, 1996	Supplement 5Manufacturing	Approved	None posted
May 14, 1996	Supplement 1Labeling	Approved	None posted
May 14, 1996	Supplement 6Manufacturing	Approved	None posted
Jan 23, 1996	Supplement 3Manufacturing	Approved	None posted
Jan 23, 1996	Supplement 4Manufacturing	Approved	None posted
Jan 4, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74136
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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