Details for New Drug Application (NDA): 016793

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NDA 016793 describes CYTARABINE, which is a drug marketed by Fresenius Kabi Usa, Gland, Hikma, Hospira, Meitheal, Pharmobedient, Rising, Teva Parenteral, and West-ward Pharms Int, and is included in nineteen NDAs. It is available from five suppliers. Additional details are available on the CYTARABINE profile page.

The generic ingredient in CYTARABINE is cytarabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cytarabine profile page.

Summary for 016793

Tradename:	CYTARABINE
Applicant:	Teva Parenteral
Ingredient:	cytarabine
Patents:	0

Medical Subject Heading (MeSH) Categories for 016793

Antimetabolites, Antineoplastic
Antiviral Agents
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 21, 1987	TE:		RLD:	Yes

Expired US Patents for NDA 016793

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-002	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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