Prempro (Premarin;Cycrin), Premphase (Premarin;Cycrin 14/14)

NDA 20303, held by Wyeth Pharms Inc. Estrogens, Conjugated; Medroxyprogesterone Acetate.

As of Nov 14, 2026, NDA 20303 (Prempro (Premarin;Cycrin), Premphase (Premarin;Cycrin 14/14)), held by Wyeth Pharms Inc, was first approved by FDA on Dec 30, 1994, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1994
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Dec 7, 2007	Supplement 4Efficacy (new indication or use)	Approved	None posted
Dec 30, 1994	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms


Prempro (Premarin;Cycrin)0.625MG,0.625MG;2.5MG,2.5MG · tablet;oral-28	Estrogens, Conjugated; Medroxyprogesterone Acetate	Discontinued
Premphase (Premarin;Cycrin 14/14)0.625MG,0.625MG;N/A,5MG · tablet;oral-28	Estrogens, Conjugated; Medroxyprogesterone Acetate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 1Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 4Efficacy (new indication or use)	Approved	None posted
Jun 28, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 27, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 14, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 13, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 30, 1994	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 20303
Drugs@FDA: Overview at FDA
Company: Wyeth Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters