Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022025
Company: CLINIGEN HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOTECT DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION 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
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
11/16/2018 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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
11/16/2018 SUPPL-18 Labeling-Patient 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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