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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019641

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NDA 019641 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 019641
Tradename:TERAZOL 3
Applicant:Janssen Pharms
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 019641
Suppliers and Packaging for NDA: 019641
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOL 3 terconazole SUPPOSITORY;VAGINAL 019641 NDA Janssen Pharmaceuticals, Inc. 50458-531 50458-531-01 1 DOSE PACK in 1 CARTON (50458-531-01) > 3 SUPPOSITORY in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;VAGINALStrength80MG
Approval Date:May 24, 1988TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Chinese Patent Office

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