Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040228
Company: ELITE LABS INC
Company: ELITE LABS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 06/19/1997 | 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-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |