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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Chinese Patent Office
Fish and Richardson
Cantor Fitzgerald
Queensland Health

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 081214

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NDA 081214 describes ESTROPIPATE, which is a drug marketed by Barr, Duramed Pharms Barr, Mylan, Watson Labs, and Watson Labs Teva, 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 081214
Applicant:Watson Labs
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 081214
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTROPIPATE estropipate TABLET;ORAL 081214 ANDA Actavis Pharma, Inc. 0591-0415 N 0591-0415-05
ESTROPIPATE estropipate TABLET;ORAL 081214 ANDA Actavis Pharma, Inc. 0591-0415 N 0591-0415-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1.5MG
Approval Date:Sep 23, 1993TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
US Department of Justice
Daiichi Sankyo

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