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Generated: November 18, 2018

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Details for New Drug Application (NDA): 020216

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NDA 020216 describes PREMARIN, which is a drug marketed by Wyeth Pharms and is included in three NDAs. It is available from six 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. Six suppliers are listed for this compound. Additional details are available on the estrogens, conjugated profile page.
Summary for 020216
Tradename:PREMARIN
Applicant:Wyeth Pharms
Ingredient:estrogens, conjugated
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020216
Suppliers and Packaging for NDA: 020216
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREMARIN estrogens, conjugated CREAM;TOPICAL, VAGINAL 020216 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0046-0872 0046-0872-04 1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-04) > 4 g in 1 TUBE, WITH APPLICATOR
PREMARIN estrogens, conjugated CREAM;TOPICAL, VAGINAL 020216 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0046-0872 0046-0872-21 1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-21) > 30 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICAL, VAGINALStrength0.625MG/GM
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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