Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076023
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/11/2003 | 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 |
|---|---|---|---|---|---|
| 09/18/2018 | SUPPL-19 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2018 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/30/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/30/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |