Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040283
Company: OXFORD PHARMS
Company: OXFORD PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40283ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-283_Carisoprodol%20Aspirin%20Codeine%20Phosphate.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/29/2017 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |