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 two 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. Two 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

Mechanism of Action	Estrogen Receptor Agonists

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:	RX	Dosage:	CREAM;TOPICAL, VAGINAL			Strength	0.625MG/GM
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 020216

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMARIN	estrogens, conjugated	CREAM;TOPICAL, VAGINAL	020216-001	Approved Prior to Jan 1, 1982	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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