Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215037
Company: ZYDUS PHARMS

Products on ANDA 215037

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215037

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215037

NELARABINE

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