Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040860
Company: INGENUS PHARMS NJ
Company: INGENUS PHARMS NJ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE | ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE | 325MG;200MG;16MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/07/2010 | 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 |
|---|---|---|---|---|---|
| 02/22/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/22/2024 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/07/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-3 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |