Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074245
Company: WEST-WARD PHARMS INT

Products on ANDA 074245

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTARABINE	CYTARABINE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes
CYTARABINE	CYTARABINE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074245

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/1994	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
10/13/2000	SUPPL-4	Labeling		Label is not available on this site.
03/27/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/23/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/11/1997	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074245

CYTARABINE

INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTARABINE	CYTARABINE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211938	GLAND
CYTARABINE	CYTARABINE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	074245	WEST-WARD PHARMS INT