Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020303
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREMPHASE (PREMARIN;CYCRIN 14/14) ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.625MG,0.625MG;N/A,5MG TABLET;ORAL-28 Discontinued None No No
PREMPRO (PREMARIN;CYCRIN) ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.625MG,0.625MG;2.5MG,2.5MG TABLET;ORAL-28 Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/1994 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/27/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-4 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

12/14/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-1 Labeling

Label is not available on this site.

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