Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084471
Company: PURACAP PHARM
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
02/25/1975 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
06/30/1989 SUPPL-27 Bioequivalence

Label is not available on this site.

06/10/1988 SUPPL-21 Labeling

Label is not available on this site.

02/18/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/25/1981 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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