Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212034
Company: ACCORD HLTHCARE

Products on ANDA 212034

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212034

CLOFARABINE

SOLUTION;INTRAVENOUS; 20MG/20ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212034	ACCORD HLTHCARE
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208857	AMNEAL
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	205375	DR REDDYS
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207831	GLAND
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213461	MEITHEAL
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209775	MSN
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208860	NORVIUM BIOSCIENCE
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216233	SCINOPHARM TAIWAN
CLOLAR	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021673	GENZYME