Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076571
Company: FRESENIUS KABI USA

Products on ANDA 076571

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLADRIBINE	CLADRIBINE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076571

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076571

CLADRIBINE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLADRIBINE	CLADRIBINE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076571	FRESENIUS KABI USA
CLADRIBINE	CLADRIBINE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075405	HIKMA
CLADRIBINE	CLADRIBINE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210856	HISUN PHARM HANGZHOU