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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Teva
Colorcon
Mallinckrodt
Cantor Fitzgerald
US Army
US Department of Justice
Deloitte
Fish and Richardson

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019579

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NDA 019579 describes TERAZOL 7, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from three suppliers. Additional details are available on the TERAZOL 7 profile page.

The generic ingredient in TERAZOL 7 is terconazole. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the terconazole profile page.
Summary for 019579
Tradename:TERAZOL 7
Applicant:Janssen Pharms
Ingredient:terconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 019579
Ingredient-typeAzoles
Suppliers and Packaging for NDA: 019579
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOL 7 terconazole CREAM;VAGINAL 019579 NDA AUTHORIZED GENERIC Actavis Pharma, Inc 0591-3196 N 0591-3196-89
TERAZOL 7 terconazole CREAM;VAGINAL 019579 NDA Janssen Pharmaceuticals, Inc. 50458-535 N 50458-535-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;VAGINALStrength0.4%
Approval Date:Dec 31, 1987TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Fuji
Colorcon
Merck
McKesson
Deloitte
Chubb
Baxter

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