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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079114

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NDA 079114 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. Fifty suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 079114
Applicant:Perrigo R And D
Ingredient:miconazole nitrate
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 079114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MICONAZOLE NITRATE miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 079114 ANDA L. Perrigo Company 0113-0916 N 0113-0916-00
MICONAZOLE NITRATE miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 079114 ANDA L. Perrigo Company 0113-7199 N 0113-7199-00

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM, SUPPOSITORY;TOPICAL, VAGINALStrength2%,1.2GM
Approval Date:Jun 2, 2010TE:RLD:No

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