Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010028
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EQUANIL MEPROBAMATE 400MG TABLET;ORAL Discontinued None No No
EQUANIL MEPROBAMATE 200MG 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
07/26/1955 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/1988 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/05/1988 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1987 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/08/1986 SUPPL-21 Labeling

Label is not available on this site.

01/16/1981 SUPPL-19 Labeling

Label is not available on this site.

07/24/1979 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/30/1978 SUPPL-17 Labeling

Label is not available on this site.

08/18/1977 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/09/1976 SUPPL-15 Labeling

Label is not available on this site.

06/23/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

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