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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/10/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021710lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021710ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021710s000_EquetroTOC.cfm |
Supplements
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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021710s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021710Orig1s018ltr.pdf | |
01/27/2012 | SUPPL-13 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021710s013ltr.pdf |
09/23/2016 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021710Orig1s011,s012ltr.pdf | |
09/23/2016 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021710Orig1s011,s012ltr.pdf | |
11/13/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021710s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021710Orig1s009ltr.pdf | |
10/24/2010 | SUPPL-8 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021710s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021710s008ltr.pdf | |
04/23/2009 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021710s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021710s006ltr.pdf | |
12/19/2007 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021710s005ltr.pdf |
12/09/2006 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021710s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021710s003ltr.pdf |
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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021710s008lbl.pdf | |
10/24/2010 | SUPPL-8 | REMS-Proposal | 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 |