Viewing data from:

M-ZOLE 3 COMBINATION PACK

ANDA

MICONAZOLE NITRATE | A074926 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs11 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

ERREGIERRE SPAMICONAZOLE NITRATE

DMF 68701987

YUNG ZIP CHEMICAL IND CO LTDMICONAZOLE NITRATE

DMF 69821987

FDC LTDMICONAZOLE NITRATE USP

DMF 73761988

QUIMICA SINTETICA SAMICONAZOLE NITRATE

DMF 82051989

OLON SPAMICONAZOLE NITRATE

DMF 105181993

NV AJINOMOTO OMNICHEM SAMICONAZOLE NITRATE

DMF 279042014

PRANAMI DRUGS PRIVATE LTDMICONAZOLE NITRATE USP

DMF 423072025

PROFARMACO SRLInactiveMICONAZOLE NITRATE & BASE

DMF 46531982

PROSINTEX INDUSTRIE CHIMIQUE ITALIANE SRLInactiveMICONAZOLE NITRATE

DMF 68821987

SIBEFAT SPAInactiveMICONAZOLE NITRATE

DMF 80951989

SUMIKA FINE CHEMICALS CO LTDInactiveMICONAZOLE NITRATE

DMF 84711990

CHEMI SPAInactiveMICONAZOLE NITRATE

DMF 95401992

ISOCHEM SAInactiveMICONAZOLE NITRATE

DMF 97931992

JANSSEN PHARMACEUTICA NVInactiveMICONAZOLE NITRATE DRUG SUBSTANCE

DMF 109131994

GUANGDONG PHARMACEUTICAL FACTORYInactiveMICONAZOLE NITRATE

DMF 109701994

CORDEN PHARMA BERGAMO SPAInactiveMICONAZOLE NITRATE

DMF 115621995

GUFIC BIOSCIENCES LTDInactiveMICONAZOLE NITRATE USP

DMF 124551997

CATALENT PHARMA SOLUTIONS LLCInactiveMICONAZOLE NITRATE (1,200MG) VAGINAL OVULE SOFT-GELATIN CAPSULE

DMF 129381998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 16, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2%,200MG

0 patents0 exclusivities▴

CREAM, SUPPOSITORY;TOPICAL, VAGINAL | Approved: Apr 16, 1999

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Applicant name for M-Zole 3 Combination Pack (miconazole nitrate) NDA 074926 changed from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated the applicant name for miconazole nitrate M-ZOLE 3 Combination Pack (NDA 074926) from "Cosette" to "Cosette Pharms NC" in the FDA Orange Book.

Old: COSETTE

New: COSETTE PHARMS NC