Drugs@FDA: FDA Approved Drug Products

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

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