Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084927
Company: IMPAX LABS
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
08/20/1976 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
01/25/1989 SUPPL-31 Labeling

Label is not available on this site.

12/22/1988 SUPPL-30 Labeling

Label is not available on this site.

11/10/1987 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/03/1987 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/15/1988 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/02/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/15/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/15/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/20/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/20/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

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