Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011792
Company: MYLAN SPECIALITY LP
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOMA | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | AA | Yes | No |
| SOMA | CARISOPRODOL | 250MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SOMA | CARISOPRODOL | 250MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/04/2019 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011792s050lbl.pdf | |
| 08/22/2018 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011792s048lbl.pdf | |
| 02/01/2013 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf | |
| 02/01/2013 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf | |
| 11/17/2009 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011792s043lbl.pdf | |
| 09/13/2007 | SUPPL-41 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011792s041lbl.pdf | |
| 06/07/2006 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011792s035lbl.pdf |