Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020303
Company: WYETH PHARMS INC

• Other Important Information from FDA

Products on NDA 020303

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020303

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.