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Generated: May 25, 2017

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Details for New Drug Application (NDA): 074164

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NDA 074164 describes MICONAZOLE 7, which is a drug marketed by Actavis Mid Atlantic and G And W Labs and is included in two NDAs. It is available from sixteen suppliers. Additional details are available on the MICONAZOLE 7 profile page.

The generic ingredient in MICONAZOLE 7 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: 074164

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 074164

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
miconazole nitrate
CREAM;VAGINAL 074164 ANDA Walgreen Company 0363-0730 0363-0730-41 7 TUBE in 1 CARTON (0363-0730-41) > 45 g in 1 TUBE
miconazole nitrate
CREAM;VAGINAL 074164 ANDA Actavis Pharma, Inc. 0472-0730 0472-0730-41 7 TUBE in 1 CARTON (0472-0730-41) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;VAGINALStrength2%
Approval Date:Mar 29, 1996TE:RLD:No

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