Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084487
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 |
|---|---|---|---|---|---|---|---|
| 04/09/1982 | 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 |
|---|---|---|---|---|---|
| 09/17/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/22/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 04/05/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/22/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/22/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/22/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/02/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |