Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080699
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPROBAMATE MEPROBAMATE 200MG TABLET;ORAL Discontinued None No No
MEPROBAMATE MEPROBAMATE 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
10/16/1972 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/1998 SUPPL-130 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-129 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-128 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-126 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-125 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-124 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-123 Manufacturing (CMC)

Label is not available on this site.

03/15/1989 SUPPL-122 Labeling

Label is not available on this site.

10/13/1988 SUPPL-121 Labeling

Label is not available on this site.

03/12/1986 SUPPL-118 Manufacturing (CMC)

Label is not available on this site.

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