Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021710
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EQUETRO | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| EQUETRO | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| EQUETRO | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/14/2022 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021710s018lbl.pdf | |
| 09/23/2016 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf | |
| 09/23/2016 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf | |
| 11/13/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021710s009lbl.pdf | |
| 10/24/2010 | SUPPL-8 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021710s008lbl.pdf | |
| 10/24/2010 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021710s008lbl.pdf | |
| 04/23/2009 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021710s006lbl.pdf | |
| 12/09/2006 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021710s003lbl.pdf | |
| 12/10/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021710lbl.pdf |