Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087764
Company: SHIRE RICHWOOD
Company: SHIRE RICHWOOD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OBY-TRIM | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
03/18/1982 | 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 |
---|---|---|---|---|---|
07/06/1989 | SUPPL-8 | Bioequivalence |
Label is not available on this site. |
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07/30/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/15/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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12/07/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |