Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075982
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/2002 | 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-14 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 03/12/2008 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/2008 | SUPPL-10 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/12/2008 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/09/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |