Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078394
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE AND IBUPROFEN | IBUPROFEN; OXYCODONE HYDROCHLORIDE | 400MG;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 |
|---|---|---|---|---|---|---|---|
| 11/26/2007 | 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 |
|---|---|---|---|---|---|
| 09/21/2018 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-15 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 05/24/2019 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |