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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Boehringer Ingelheim
US Department of Justice
Johnson and Johnson

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074366

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NDA 074366 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-four suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for NDA: 074366

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 074366

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
miconazole nitrate
CREAM;VAGINAL 074366 ANDA G&W Laboratories, Inc. 0713-0252 0713-0252-37 45 g in 1 TUBE, WITH APPLICATOR (0713-0252-37)
miconazole nitrate
CREAM;VAGINAL 074366 ANDA Central Texas Community Health Centers 76413-318 76413-318-45 1 TUBE, WITH APPLICATOR in 1 CARTON (76413-318-45) > 45 g in 1 TUBE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;VAGINALStrength2%
Approval Date:Feb 22, 1996TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Fish and Richardson
Farmers Insurance
Cantor Fitzgerald
US Army
Daiichi Sankyo

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