Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088605
Company: SANDOZ INC
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1987 | 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 |
|---|---|---|---|---|---|
| 05/31/2017 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/31/2001 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/31/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/31/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/31/2001 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/20/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/20/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/15/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 09/15/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 06/25/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |