Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012366
Company: MEDA PHARMS
Company: MEDA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOMA COMPOUND W/ CODEINE | ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE | 325MG;200MG;16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/09/2013 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s034lbl.pdf | |
| 01/31/2013 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s033lbl.pdf | |
| 11/06/2009 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012366s032lbl.pdf | |
| 10/23/2008 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012366s031lbl.pdf |