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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 020303

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NDA 020303 describes PREMPRO (PREMARIN;CYCRIN), which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. Additional details are available on the PREMPRO (PREMARIN;CYCRIN) profile page.

The generic ingredient in PREMPRO (PREMARIN;CYCRIN) 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 020303

Tradename:	PREMPRO (PREMARIN;CYCRIN)
Applicant:	Wyeth Pharms Inc
Ingredient:	estrogens, conjugated; medroxyprogesterone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.625MG,0.625MG;2.5MG,2.5MG
Approval Date:	Dec 30, 1994	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.625MG,0.625MG;N/A,5MG
Approval Date:	Dec 30, 1994	TE:		RLD:	No

Expired US Patents for NDA 020303

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	PREMPHASE (PREMARIN;CYCRIN 14/14)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-002	Dec 30, 1994	⤷ Get Started Free	⤷ Get Started Free
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994	⤷ Get Started Free	⤷ Get Started Free
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994	⤷ Get Started Free	⤷ Get Started Free
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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