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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022275
Company: OTSUKA

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 022275

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAMSCA	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	AB	Yes	No
SAMSCA	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	AB	Yes	Yes
SAMSCA	TOLVAPTAN	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022275

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2009	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022275lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022275s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2021	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022275s017lbl.pdf
04/23/2018	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022275Orig1s016ltr.pdf
06/01/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022275s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022275Orig1s015ltr.pdf
02/28/2014	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022275Orig1s014ltr.pdf
05/02/2013	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s011ltr.pdf
09/27/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/09/2013	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s009ltr.pdf
09/14/2012	SUPPL-8	REMS-Assessment, REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s008ltr.pdf
11/16/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s007ltr.pdf
02/01/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275s005ltr.pdf
09/23/2011	SUPPL-3	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022275s003ltr.pdf

Labels for NDA 022275

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2021	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022275s017lbl.pdf
04/22/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022275s017lbl.pdf
04/23/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbledt.pdf
06/01/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022275s015lbl.pdf
02/28/2014	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf
02/28/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf
05/02/2013	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s011lbl.pdf
04/09/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s009lbl.pdf
11/16/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf
02/01/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s005lbl.pdf
05/19/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022275lbl.pdf

Therapeutic Equivalents for NDA 022275

SAMSCA

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAMSCA	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	Yes	AB	022275	OTSUKA
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	211891	ALKEM LABS LTD
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	207605	APOTEX
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	205646	HETERO LABS LTD V
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	216949	MSN
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	206119	PAR PHARM INC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAMSCA	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	Yes	AB	022275	OTSUKA
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	211891	ALKEM LABS LTD
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	207605	APOTEX
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	205646	HETERO LABS LTD V
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	216949	MSN
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	206119	PAR PHARM INC

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