Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084276
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOCARBAMOL METHOCARBAMOL 750MG 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
01/04/1977 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
09/28/2007 SUPPL-52 Labeling

Label is not available on this site.

11/13/2002 SUPPL-47 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/25/2001 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1999 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

06/08/1999 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

09/22/1998 SUPPL-42 Labeling

Label is not available on this site.

09/22/1998 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/22/1998 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/22/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/02/1988 SUPPL-32 Bioequivalence

Label is not available on this site.

02/26/1987 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/02/1985 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/02/1985 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/02/1985 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/02/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/16/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/04/1984 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/16/1982 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/16/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/05/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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