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Johnson and Johnson
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Federal Trade Commission
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Generated: May 20, 2018

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 Perrigo R And D, G And W Labs Inc, Perrigo, Taro, Teva, Teva Pharms, Actavis Pharma, and G And W Labs, and is included in twelve NDAs. It is available from thirty 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. Forty-nine suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 074444
Tradename:MICONAZOLE NITRATE
Applicant:Taro
Ingredient:miconazole nitrate
Patents:0
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 miconazole nitrate CREAM;VAGINAL 074444 ANDA Shopko Stores Operating Co., LLC 37012-035 N 37012-035-07
MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074444 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-2035 N 51672-2035-6

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Cerilliant
Covington
Merck
Moodys
Cipla
Daiichi Sankyo
UBS

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