Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076512
Company: FRESENIUS KABI USA

Products on ANDA 076512

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTARABINE	CYTARABINE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076512

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/15/2004	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
08/12/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076512

CYTARABINE

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTARABINE	CYTARABINE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076512	FRESENIUS KABI USA
CYTARABINE	CYTARABINE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075383	HOSPIRA
CYTARABINE	CYTARABINE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205696	MEITHEAL
CYTARABINE	CYTARABINE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	201784	RISING