Details for New Drug Application (NDA): 004782

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NDA 004782 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 004782

Tradename:	PREMARIN
Applicant:	Wyeth Pharms
Ingredient:	estrogens, conjugated
Patents:	0

Pharmacology for NDA: 004782

Mechanism of Action	Estrogen Receptor Agonists

Suppliers and Packaging for NDA: 004782

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREMARIN	estrogens, conjugated	TABLET;ORAL	004782	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0046-1100	0046-1100-52	1 BLISTER PACK in 1 CARTON (0046-1100-52) / 5 TABLET, FILM COATED in 1 BLISTER PACK
PREMARIN	estrogens, conjugated	TABLET;ORAL	004782	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0046-1100	0046-1100-81	100 TABLET, FILM COATED in 1 BOTTLE (0046-1100-81)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1.25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.3MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 004782

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMARIN	estrogens, conjugated	TABLET;ORAL	004782-005	Jan 26, 1984	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PREMARIN	estrogens, conjugated	TABLET;ORAL	004782-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PREMARIN	estrogens, conjugated	TABLET;ORAL	004782-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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