Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009698
Company: MEDPOINTE PHARM HLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MILTOWN MEPROBAMATE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MILTOWN MEPROBAMATE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
04/28/1955 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
12/13/2001 SUPPL-36 Labeling

Label is not available on this site.

12/13/2001 SUPPL-35 Labeling

Label is not available on this site.

01/18/1994 SUPPL-34 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/09/1993 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1986 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/01/1986 SUPPL-29 Labeling

Label is not available on this site.

07/29/1981 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/19/1980 SUPPL-23 Labeling

Label is not available on this site.

03/10/1980 SUPPL-22 Labeling

Label is not available on this site.

04/04/1979 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/12/1978 SUPPL-20 Labeling

Label is not available on this site.

08/26/1974 SUPPL-16 Unspecified

Label is not available on this site.

01/15/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

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