Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084616
Company: FOSUN PHARMA
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
12/19/1975 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
04/28/2008 SUPPL-85 Labeling

Label is not available on this site.

04/19/2002 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/2001 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1999 SUPPL-73 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/05/1999 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

09/28/1998 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

09/28/1998 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

09/28/1998 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

09/22/1995 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

03/07/1995 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

07/23/1990 SUPPL-65 Labeling

Label is not available on this site.

03/21/1989 SUPPL-63 Labeling

Label is not available on this site.

02/09/1989 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

03/05/1987 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

08/16/1985 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/24/1985 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

07/17/1984 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

07/17/1984 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

09/19/1984 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/17/1983 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

06/17/1983 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/23/1983 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

07/28/1982 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/06/1982 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/04/1982 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/04/1982 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

02/14/1984 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

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