Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200915
Company: RISING

Products on ANDA 200915

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200915

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2011	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/09/2015	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200915

CYTARABINE

INJECTABLE;INJECTION; 20MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	071868	HOSPIRA
CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	072168	HOSPIRA
CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	072945	HOSPIRA
CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208485	MEITHEAL
CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	200915	RISING