FDA Orange Book · active-ingredient family
Miconazole nitrate
Miconazole nitrate: 11 brands, 18 generics; first approved Aug 15, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
11
Generics (ANDA)
18
Listed patents
0
Presentations
30
Brand (NDA) products
Originator applications
- MEDTECH PRODUCTSNDA 02126120032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,4% CREAM TOPICAL, VAGINAL OTC - 2%,4% CREAM TOPICAL, VAGINAL OTC - - MEDTECH PRODUCTSNDA 0213082001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,1.2GM CREAM, INSERT TOPICAL, VAGINAL OTC - - MEDTECH PRODUCTSNDA 0208271998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% CREAM VAGINAL OTC - - MEDTECH PRODUCTSNDA 0206701996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,200MG CREAM, SUPPOSITORY TOPICAL, VAGINAL OTC - - MEDTECH PRODUCTSNDA 0202881993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,100MG CREAM, SUPPOSITORY TOPICAL, VAGINAL OTC - - MEDTECH PRODUCTSNDA 0174501991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM VAGINAL OTC - - MEDTECH PRODUCTSNDA 0185201991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG SUPPOSITORY VAGINAL OTC - - MEDTECH PRODUCTSNDA 0188881984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG SUPPOSITORY VAGINAL Rx AB - PERSONAL PRODSNDA 0185921989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TAMPON VAGINAL Discontinued - - INSIGHT PHARMSNDA 017494-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM TOPICAL Discontinued - - INSIGHT PHARMSNDA 017739-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% LOTION TOPICAL Discontinued -
Generic (ANDA) products (18)
Abbreviated applications
- MICONAZOLE NITRATEPERRIGO R AND DANDA 0791142010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,1.2GM CREAM, INSERT TOPICAL, VAGINAL OTC - - MICONAZOLE NITRATEPERRIGO R AND DANDA 0913662010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% CREAM VAGINAL OTC - - SUN PHARMA CANADAANDA 0767732005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% CREAM VAGINAL OTC - - PERRIGOANDA 0763572004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,4% CREAM TOPICAL, VAGINAL OTC - - COSETTE PHARMS NCANDA 0765852004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,100MG CREAM, SUPPOSITORY TOPICAL, VAGINAL Discontinued - - L PERRIGO COANDA 0753291999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,200MG CREAM, SUPPOSITORY TOPICAL, VAGINAL OTC - - COSETTE PHARMS NCANDA 0749261999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,200MG CREAM, SUPPOSITORY TOPICAL, VAGINAL OTC - - ACTAVIS MID ATLANTICANDA 0745861997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2%,100MG CREAM, SUPPOSITORY TOPICAL, VAGINAL Discontinued - - MICONAZOLE NITRATEPERRIGOANDA 0747601997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM VAGINAL OTC - - MICONAZOLE NITRATECOSETTE PHARMS NCANDA 0744141997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG SUPPOSITORY VAGINAL Discontinued - - MICONAZOLE NITRATEPERRIGOANDA 0743951997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG SUPPOSITORY VAGINAL Discontinued - - MICONAZOLE NITRATESUN PHARMA CANADAANDA 0744441997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM VAGINAL OTC - - ENCUBEANDA 0741641996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM VAGINAL OTC - - MICONAZOLE NITRATECOSETTE PHARMS NCANDA 0743661996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM VAGINAL Discontinued - - MICONAZOLE NITRATETEVAANDA 0741361995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM VAGINAL Discontinued - - MICONAZOLE NITRATEACTAVIS PHARMAANDA 0735081993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG SUPPOSITORY VAGINAL Rx AB - MICONAZOLE NITRATECOSETTE PHARMS NCANDA 0735071993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG SUPPOSITORY VAGINAL OTC - - MICONAZOLE NITRATETEVA PHARMSANDA 0740301992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM VAGINAL Discontinued -
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
42 yr 10 mo ago
Most recent approval
16 yr 8 mo ago
Approvals span 1984–2010 across 29 FDA applications.
Brand (NDA) 1138%
Generic (ANDA) 1862%
Miconazole nitrate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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