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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204029
Company: ABON PHARMS LLC

Products on ANDA 204029

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 204029

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2017	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204029Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204029Orig1s000ltr.pdf

Labels for ANDA 204029

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204029Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 204029

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	204029	ABON PHARMS LLC
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 PHARMA LTD
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	MYLAN LABS LTD
CLOLAR	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021673	GENZYME

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