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Details for New Drug Application (NDA): 075953

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NDA 075953 describes TERCONAZOLE, which is a drug marketed by Fougera Pharms, Nycomed Us, Taro, and Perrigo New York, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the TERCONAZOLE profile page.

The generic ingredient in TERCONAZOLE is terconazole. There are six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the terconazole profile page.

Summary for NDA: 075953

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 075953


Suppliers and Packaging for NDA: 075953

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CREAM;VAGINAL 075953 ANDA A-S Medication Solutions 50090-1196 50090-1196-0 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-1196-0) > 20 g in 1 TUBE, WITH APPLICATOR
CREAM;VAGINAL 075953 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1302 51672-1302-0 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1302-0) > 20 g in 1 TUBE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength0.8%
Approval Date:Apr 6, 2004TE:ABRLD:No

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