Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078778
Company: MPP PHARMA
Company: MPP PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/07/2014 | 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 |
|---|---|---|---|---|---|
| 12/29/2025 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/01/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 12/01/2023 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-7 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 12/01/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2016 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |