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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201784
Company: RISING

Products on ANDA 201784

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201784

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2012	ORIG-1	Approval	Not Applicable		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201784Orig1s000Approv.pdf

Therapeutic Equivalents for ANDA 201784

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

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