Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087918
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/1983 | 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 |
|---|---|---|---|---|---|
| 10/06/2000 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/01/1999 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/03/1998 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/19/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/08/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/19/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/16/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/06/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/15/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |