Details for New Drug Application (NDA): 020527

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NDA 020527 describes PREMPRO, which is a drug marketed by Wyeth Pharms and Wyeth Pharms Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the PREMPRO profile page.

The generic ingredient in PREMPRO is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.

Summary for 020527

Tradename:	PREMPRO
Applicant:	Wyeth Pharms
Ingredient:	estrogens, conjugated; medroxyprogesterone acetate
Patents:	0

Pharmacology for NDA: 020527

Mechanism of Action	Estrogen Receptor Agonists

Suppliers and Packaging for NDA: 020527

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0046-1105	0046-1105-11	1 BLISTER PACK in 1 CARTON (0046-1105-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK
PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0046-1106	0046-1106-11	1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.625MG;2.5MG
Approval Date:	Nov 17, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.625MG,0.625MG;N/A,5MG
Approval Date:	Nov 17, 1995	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.625MG;5MG
Approval Date:	Jan 9, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020527

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-005	Jun 4, 2003	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PREMPHASE 14/14	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-002	Nov 17, 1995	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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