Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088430
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 03/27/1984 | 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 |
|---|---|---|---|---|---|
| 10/18/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/24/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/24/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/09/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |