Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085159
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOCARBAMOL METHOCARBAMOL 500MG 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
08/11/1976 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
12/07/2015 SUPPL-51 Labeling-Container/Carton Labels

Label is not available on this site.

10/28/2002 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/12/2002 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-38 Labeling

Label is not available on this site.

03/11/1999 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/22/1996 SUPPL-32 Labeling

Label is not available on this site.

02/22/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/13/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/13/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/13/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/02/1992 SUPPL-27 Labeling

Label is not available on this site.

09/17/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/04/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/02/1989 SUPPL-19 Labeling

Label is not available on this site.

04/09/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/09/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/09/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/20/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/27/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/21/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/01/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/01/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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