Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084471
Company: PURACAP PHARM
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. |
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06/10/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
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02/18/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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09/25/1981 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |