Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016793
Company: TEVA PARENTERAL

Products on NDA 16793

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTARABINE	CYTARABINE	100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CYTARABINE	CYTARABINE	500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CYTARABINE	CYTARABINE	1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CYTARABINE	CYTARABINE	2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Labels for NDA 016793

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/1998	SUPPL-59	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/016793s059lbl.pdf