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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Farmers Insurance
Johnson and Johnson

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019964

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NDA 019964 describes TERAZOL 3, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from four suppliers. Additional details are available on the TERAZOL 3 profile page.

The generic ingredient in TERAZOL 3 is terconazole. There are six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the terconazole profile page.
Summary for 019964
Tradename:TERAZOL 3
Applicant:Janssen Pharms
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 019964
Suppliers and Packaging for NDA: 019964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOL 3 terconazole CREAM;VAGINAL 019964 NDA AUTHORIZED GENERIC Actavis Pharma, Inc 0591-3197 N 0591-3197-52
TERAZOL 3 terconazole CREAM;VAGINAL 019964 NDA Rebel Distributors Corp 21695-933 E 21695-933-20

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;VAGINALStrength0.8%
Approval Date:Feb 21, 1991TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Boehringer Ingelheim

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