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MONISTAT 3 COMBINATION PACK (PREFILLED)

NDA

MICONAZOLE NITRATE | N021261 | MEDTECH PRODUCTS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

5 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2022	SUPPL -25	View Letter (PDF)
Jan 29, 2020	SUPPL -24	View Letter (PDF)
Oct 30, 2008	SUPPL -7	View Letter (PDF)
Jun 22, 2003	SUPPL -4	View Letter (PDF)
Feb 2, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#003 — 2%,4%

RLD

0 patents0 exclusivities▾

CREAM;TOPICAL, VAGINAL | Approved: Jun 17, 2003

#001 — 2%,4%

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL, VAGINAL | Approved: Feb 2, 2001

No patent or exclusivity listings for this strength.