Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085123
Company: HIKMA INTL 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
08/18/1976 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
05/08/2015 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

10/28/2002 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/12/2002 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-37 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/01/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-34 Labeling

Label is not available on this site.

03/11/1999 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/08/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/22/1996 SUPPL-28 Labeling

Label is not available on this site.

02/22/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/13/1995 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/13/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/13/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/17/1992 SUPPL-23 Labeling

Label is not available on this site.

11/21/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/02/1989 SUPPL-18 Labeling

Label is not available on this site.

02/04/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/02/1989 SUPPL-15 Labeling

Label is not available on this site.

04/09/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/09/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/09/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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