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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021877
Company: SANDOZ

Products on NDA 021877

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARRANON	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021877

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2005	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021877lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021877ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021877_s000_ArranonTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2019	SUPPL-12		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021877Orig1s012correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021877Orig1s012correctedltr.pdf
07/31/2019	SUPPL-10	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021877s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021877Orig1s010ltr.pdf
11/29/2018	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021877s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/21877Orig1s009ltr.pdf
07/03/2018	SUPPL-8	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021877Orig1s008ltr.pdf
06/04/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/06/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021877s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021877s005ltr.pdf
12/15/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021877s001s002ltr.pdf
12/15/2009	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021877s001s002ltr.pdf

Labels for NDA 021877

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2019	SUPPL-12	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021877Orig1s012correctedlbl.pdf
07/31/2019	SUPPL-10	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021877s010lbl.pdf
11/29/2018	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021877s009lbl.pdf
02/06/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021877s005lbl.pdf
12/15/2009	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf
12/15/2009	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021877s001lbl.pdf
10/28/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021877lbl.pdf

Therapeutic Equivalents for NDA 021877

ARRANON

INJECTABLE;INTRAVENOUS; 250MG/50ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARRANON	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021877	SANDOZ
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	218554	ALEMBIC
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216346	AMNEAL
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216934	DR REDDYS
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	212605	GLAND PHARMA LTD
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216038	MEITHEAL
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216948	MSN
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215057	NEXUS
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	214809	SHORLA
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216510	XGEN PHARMS
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215037	ZYDUS PHARMS

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