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Generated: September 26, 2018

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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 one supplier. 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. One supplier is listed for this compound. Additional details are available on the estropipate profile page.
Summary for 081214
Tradename:ESTROPIPATE
Applicant:Watson Labs
Ingredient:estropipate
Patents:0
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 0591-0415-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0415-01)
ESTROPIPATE estropipate TABLET;ORAL 081214 ANDA Actavis Pharma, Inc. 0591-0415 0591-0415-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-0415-05)

Profile for product number 001

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

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