Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010971
Company: WYETH AYERST

Products on NDA 010971

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PMB 200	ESTROGENS, CONJUGATED; MEPROBAMATE	0.45MG;200MG	TABLET;ORAL	Discontinued	None	No	No
PMB 400	ESTROGENS, CONJUGATED; MEPROBAMATE	0.45MG;400MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010971

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/1957	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-48	Manufacturing (CMC)-Control		Label is not available on this site.
12/27/1995	SUPPL-46	Manufacturing (CMC)-Control		Label is not available on this site.
02/23/1990	SUPPL-44	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/20/1988	SUPPL-43	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/07/1995	SUPPL-42	Labeling		Label is not available on this site.
05/17/1987	SUPPL-41	Manufacturing (CMC)-Control		Label is not available on this site.
04/11/1986	SUPPL-39	Labeling		Label is not available on this site.