Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021877
Company: NOVARTIS

Products on NDA 21877

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

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