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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084488
Company: SUN PHARM INDUSTRIES
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
07/11/1975 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
12/01/1998 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/03/1989 SUPPL-44 Labeling

Label is not available on this site.

04/06/1987 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

12/17/1987 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/07/1986 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/06/1985 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/23/1984 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/19/1985 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/10/1983 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

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