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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021248
Company: CEPHALON

Products on NDA 021248

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRISENOX	ARSENIC TRIOXIDE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
TRISENOX	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021248

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
10/20/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021248s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021248Orig1s019ltr.pdf
06/20/2019	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021248s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021248Orig1s018ltr.pdf
01/12/2018	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021248s015lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021248Orig1s015ltr.pdf
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.

Labels for NDA 021248

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021248s019lbl.pdf
06/20/2019	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021248s018lbl.pdf
01/12/2018	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021248s015lbledt.pdf
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

Therapeutic Equivalents for NDA 021248

TRISENOX

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210739	AMNEAL
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215059	GLAND PHARMA LTD
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217413	ORBICULAR
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215359	SANDOZ
ARSENIC TRIOXIDE	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206228	ZYDUS PHARMS
TRISENOX	ARSENIC TRIOXIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	021248	CEPHALON

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