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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Deloitte
Boehringer Ingelheim
AstraZeneca
Queensland Health
Teva
US Department of Justice
Novartis
Express Scripts
McKesson

Generated: June 25, 2017

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 four 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. Fourteen suppliers are listed for this compound. Additional details are available on the terconazole profile page.

Summary for NDA: 019579

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 Ortho-McNeil Pharmaceuticals 0062-5350 0062-5350-01 45 g in 1 TUBE, WITH APPLICATOR (0062-5350-01)
TERAZOL 7
terconazole
CREAM;VAGINAL 019579 NDA AUTHORIZED GENERIC Actavis Pharma, Inc 0591-3196 0591-3196-89 1 TUBE, WITH APPLICATOR in 1 CARTON (0591-3196-89) > 45 g in 1 TUBE, WITH APPLICATOR

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019579

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
TERAZOL 7
terconazole
CREAM;VAGINAL019579-001Dec 31, 19874,358,449► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Chubb
Merck
Cerilliant
Healthtrust
Moodys
Teva
Medtronic
UBS
Novartis

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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