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Serving leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Cantor Fitzgerald
Daiichi Sankyo

Generated: December 14, 2017

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

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 0591-3197-52 1 TUBE, WITH APPLICATOR in 1 CARTON (0591-3197-52) > 20 g in 1 TUBE, WITH APPLICATOR
TERAZOL 3 terconazole CREAM;VAGINAL 019964 NDA Rebel Distributors Corp 21695-933 21695-933-20 20 g in 1 TUBE, WITH APPLICATOR (21695-933-20)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019964

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsTERAZOL 3terconazoleCREAM;VAGINAL019964-001Feb 21, 1991► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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