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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Baxter
US Army
Cipla
Covington
Harvard Business School
Merck
Chubb
Chinese Patent Office

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 081215

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NDA 081215 describes ESTROPIPATE, which is a drug marketed by Watson Labs, Watson Labs Teva, Barr, Mylan, and Duramed Pharms Barr, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the ESTROPIPATE profile page.

The generic ingredient in ESTROPIPATE is estropipate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the estropipate profile page.

Summary for NDA: 081215

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 081215

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTROPIPATE
estropipate
TABLET;ORAL 081215 ANDA Actavis Pharma, Inc. 0591-0416 0591-0416-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0416-01)
ESTROPIPATE
estropipate
TABLET;ORAL 081215 ANDA Actavis Pharma, Inc. 0591-0416 0591-0416-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-0416-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Sep 23, 1993TE:RLD:No


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Serving leading biopharmaceutical companies globally:

AstraZeneca
Farmers Insurance
US Army
Covington
US Department of Justice
Argus Health
Julphar
Cantor Fitzgerald
Accenture
Citi

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