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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022025
Company: CLINIGEN

Summary Review

Products on NDA 022025

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOTECT	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022025

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022025s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022025_totect_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022025s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-20	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/02/2020	SUPPL-19	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022025s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022025Orig1s019replacementltr.pdf
11/16/2018	SUPPL-18	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022025s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022025Orig1s018ltr.pdf
02/08/2018	SUPPL-16	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022025s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022025Orig1s016ltr.pdf
06/19/2017	SUPPL-15	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022025s015lbl.pdf
02/12/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/26/2013	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022025s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022025Orig1s013ltr.pdf
03/07/2011	SUPPL-11	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022025s011ltr.pdf
09/16/2009	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022025s005ltr.pdf
02/11/2009	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022025s001ltr.pdf

Labels for NDA 022025

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2020	SUPPL-19	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022025s019lbl.pdf
11/16/2018	SUPPL-18	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022025s018lbl.pdf
11/16/2018	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022025s018lbl.pdf
11/16/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022025s018lbl.pdf
02/08/2018	SUPPL-16	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022025s016lbl.pdf
06/19/2017	SUPPL-15	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022025s015lbl.pdf
04/26/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022025s013lbl.pdf
09/16/2009	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s005lbl.pdf
02/11/2009	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022025s001lbl.pdf
09/06/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022025lbl.pdf

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