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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Boehringer Ingelheim
US Department of Justice
Johnson and Johnson

Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074444

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NDA 074444 describes MICONAZOLE NITRATE, which is a drug marketed by Actavis Pharma, Perrigo R And D, G And W Labs, Teva Pharms, Teva, Taro, Perrigo, and G And W Labs Inc, and is included in twelve NDAs. It is available from thirty-one suppliers. Additional details are available on the MICONAZOLE NITRATE profile page.

The generic ingredient in MICONAZOLE NITRATE is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for NDA: 074444

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 074444

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
miconazole nitrate
CREAM;VAGINAL 074444 ANDA Shopko Stores Operating Co., LLC 37012-035 37012-035-07 1 TUBE, WITH APPLICATOR in 1 CARTON (37012-035-07) > 45 g in 1 TUBE, WITH APPLICATOR
miconazole nitrate
CREAM;VAGINAL 074444 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-2035 51672-2035-6 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-6) > 45 g in 1 TUBE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;VAGINALStrength2%
Approval Date:Jan 13, 1997TE:RLD:No

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Serving 500+ biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Queensland Health
Farmers Insurance
Federal Trade Commission

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