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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020216

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NDA 020216 describes PREMARIN, which is a drug marketed by Wyeth Pharms Inc and is included in three NDAs. It is available from eight 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. Eight suppliers are listed for this compound. Additional details are available on the estrogens, conjugated profile page.

Summary for 020216

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
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 Inc., 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
PREMARIN estrogens, conjugated CREAM;TOPICAL, VAGINAL 020216 NDA Wyeth Pharmaceuticals Inc., 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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020216

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms IncPREMARINestrogens, conjugatedCREAM;TOPICAL, VAGINAL020216-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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