Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021248
Company: CEPHALON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRISENOX ARSENIC TRIOXIDE 1MG/ML 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
09/25/2000 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21248ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-248_Trisenox.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/20/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021248s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021248Orig1s013ltr.pdf
07/23/2010 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021248s008,s009ltr.pdf
07/23/2010 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021248s008,s009ltr.pdf
01/07/2003 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/13/2001 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/20/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021248s013lbl.pdf
07/23/2010 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf
07/23/2010 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021248s008s009lbl.pdf
09/25/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf

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