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Generated: April 24, 2019

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Details for New Drug Application (NDA): 010402

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NDA 010402 describes PREMARIN, which is a drug marketed by Wyeth Pharms and is included in three NDAs. It is available from four suppliers. Additional details are available on the PREMARIN profile page.

The generic ingredient in PREMARIN is estrogens, conjugated. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estrogens, conjugated profile page.
Summary for 010402
Tradename:PREMARIN
Applicant:Wyeth Pharms
Ingredient:estrogens, conjugated
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 010402
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 010402
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREMARIN estrogens, conjugated INJECTABLE;INJECTION 010402 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0046-0749 0046-0749-05 1 VIAL in 1 CARTON (0046-0749-05) > 25 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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