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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076773

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NDA 076773 describes MICONAZOLE 3, which is a drug marketed by Taro and Perrigo and is included in two NDAs. It is available from eight suppliers. Additional details are available on the MICONAZOLE 3 profile page.

The generic ingredient in MICONAZOLE 3 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 076773
Tradename:MICONAZOLE 3
Applicant:Taro
Ingredient:miconazole nitrate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076773
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MICONAZOLE 3 miconazole nitrate CREAM;VAGINAL 076773 ANDA Topco Associates LLC 36800-070 36800-070-09 1 TUBE, WITH APPLICATOR in 1 CARTON (36800-070-09) > 25 g in 1 TUBE, WITH APPLICATOR
MICONAZOLE 3 miconazole nitrate CREAM;VAGINAL 076773 ANDA Shopko Stores Operating Co., LLC 37012-070 37012-070-09 1 TUBE, WITH APPLICATOR in 1 CARTON (37012-070-09) > 25 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;VAGINALStrength4%
Approval Date:Mar 2, 2005TE:RLD:No

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