Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071471
Company: HIKMA

Products on ANDA 071471

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071471

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/1989	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
06/18/2004	SUPPL-11	Labeling		Label is not available on this site.
10/13/2000	SUPPL-7	Labeling		Label is not available on this site.
07/11/1997	SUPPL-6	Labeling		Label is not available on this site.
07/21/1995	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/17/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/09/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/30/1992	SUPPL-2	Labeling		Label is not available on this site.
12/18/1990	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071471

CYTARABINE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTARABINE	CYTARABINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211937	GLAND PHARMA LTD
CYTARABINE	CYTARABINE	100MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	071471	HIKMA