Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014359
Company: HALSEY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEURAMATE MEPROBAMATE 400MG TABLET;ORAL Discontinued None No No
NEURAMATE 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
07/03/1963 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
04/26/1996 SUPPL-52 Labeling

Label is not available on this site.

03/11/1981 SUPPL-50 Labeling

Label is not available on this site.

01/16/1981 SUPPL-49 Labeling

Label is not available on this site.

09/25/1980 SUPPL-48 Labeling

Label is not available on this site.

08/26/1980 SUPPL-47 Labeling

Label is not available on this site.

04/24/1980 SUPPL-46 Labeling

Label is not available on this site.

02/28/1980 SUPPL-45 Labeling

Label is not available on this site.

02/28/1980 SUPPL-43 Labeling

Label is not available on this site.

08/08/1979 SUPPL-42 Labeling

Label is not available on this site.

07/17/1979 SUPPL-41 Labeling

Label is not available on this site.

05/18/1979 SUPPL-40 Labeling

Label is not available on this site.

07/21/1978 SUPPL-38 Labeling

Label is not available on this site.

06/30/1978 SUPPL-37 Labeling

Label is not available on this site.

05/05/1978 SUPPL-36 Labeling

Label is not available on this site.

04/26/1996 SUPPL-35 Labeling

Label is not available on this site.

04/26/1996 SUPPL-32 Labeling

Label is not available on this site.

04/26/1996 SUPPL-31 Labeling

Label is not available on this site.

04/26/1996 SUPPL-30 Labeling

Label is not available on this site.

04/26/1996 SUPPL-29 Labeling

Label is not available on this site.

04/26/1996 SUPPL-28 Labeling

Label is not available on this site.

04/26/1996 SUPPL-27 Labeling

Label is not available on this site.

04/26/1996 SUPPL-26 Labeling

Label is not available on this site.

04/26/1996 SUPPL-25 Labeling

Label is not available on this site.

04/26/1996 SUPPL-22 Labeling

Label is not available on this site.

04/26/1996 SUPPL-21 Labeling

Label is not available on this site.

04/26/1996 SUPPL-20 Labeling

Label is not available on this site.

04/26/1996 SUPPL-19 Labeling

Label is not available on this site.

05/22/1975 SUPPL-18 Labeling

Label is not available on this site.

04/26/1996 SUPPL-17 Labeling

Label is not available on this site.

08/26/1974 SUPPL-16 Labeling

Label is not available on this site.

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