Miconazole Nitrate Combination Pack

ANDA 75329, held by L Perrigo Co. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 75329 (Miconazole Nitrate Combination Pack), held by L Perrigo Co, was first approved by FDA on Apr 20, 1999, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 20, 1999
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses

treats vaginal yeast infections
relieves external itching and irritation due to a vaginal yeast infection

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 20, 1999	Original application	Approved	Label Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miconazole Nitrate Combination Pack2%,200MG · cream, suppository;topical, vaginal	Miconazole Nitrate	OTC

All 8 submissions, including labeling and manufacturing supplements


May 29, 2024	Supplement 44Labeling · Standard review	Approved	None posted
May 29, 2024	Supplement 50Labeling · Standard review	Approved	None posted
Aug 21, 2017	Supplement 40Labeling · Standard review	Approved	None posted
Apr 8, 2005	Supplement 15Labeling	Approved	None posted
May 20, 2003	Supplement 9Labeling	Approved	None posted
Jan 29, 2002	Supplement 1Labeling	Approved	None posted
Jan 29, 2002	Supplement 2Labeling	Approved	None posted
Apr 20, 1999	Original application	Approved	Label Review Letter

Identifiers

Application: ANDA 75329
Drugs@FDA: Overview at FDA
Company: L. Perrigo Company

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