Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014882
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPROBAMATE MEPROBAMATE 400MG TABLET;ORAL Discontinued None No No
MEPROBAMATE 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
08/09/1963 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
08/22/1986 SUPPL-11 Labeling

Label is not available on this site.

09/22/1981 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1978 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/25/1978 SUPPL-7 Labeling

Label is not available on this site.

09/08/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1977 SUPPL-5 Labeling

Label is not available on this site.

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