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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021710
Company: VALIDUS PHARMS

Medication Guide

Products on NDA 021710

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021710

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.html

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	REMS-Proposal, Labeling	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

Labels for NDA 021710

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

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