Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/12/1981 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/87301ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/03/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/30/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/12/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/10/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/19/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/12/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/23/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |