FDA NDA · NDA020303

PREMPRO (PREMARIN;CYCRIN)

Sponsor: WYETH PHARMS INC

APPLICATION

NDA020303

TYPE

NDA

ORIGINAL APPROVAL

1994-12-30

LATEST ACTION

2007-12-07

ROUTE

ORAL-28

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

PREMPRO (PREMARIN;CYCRIN)Discontinued

ESTROGENS, CONJUGATED 0.625MG,0.625MG, MEDROXYPROGESTERONE ACETATE 2.5MG,2.5MG · TABLET · ORAL-28

PREMPHASE (PREMARIN;CYCRIN 14/14)Discontinued

ESTROGENS, CONJUGATED 0.625MG,0.625MG, MEDROXYPROGESTERONE ACETATE N/A,5MG · TABLET · ORAL-28

2007-12-07Efficacy · Supplement 4 · unknownAP

2007-12-07Labeling · Supplement 1 · standardAP

1996-06-28Manufacturing (CMC) · Supplement 6 · standardAP

1996-06-27Manufacturing (CMC) · Supplement 7 · standardAP

1995-12-14Manufacturing (CMC) · Supplement 3 · standardAP

1995-12-13Manufacturing (CMC) · Supplement 2 · standardAP

1994-12-30Type 4 - New Combination · Original · standard — Other Important Information from FDA ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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