Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040118
Company: SANDOZ
Company: SANDOZ
| 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 |
|---|---|---|---|---|---|---|---|
| 04/16/1996 | 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-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/16/2019 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-17 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/21/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 02/02/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/01/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |