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Cytarabine - Generic Drug Details

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Cytarabine is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Fresenius Kabi Usa, Mylan Labs Ltd, Mylan Pharms Inc, Pacira Pharms Inc, Eurohlth Intl Sarl, Hospira, and Teva Parenteral, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for cytarabine. Six suppliers are listed for this compound.

Summary for Generic Name: cytarabine

Tradenames:3
Patents:0
Applicants:8
NDAs:15
Drug Master File Entries: see list15
Suppliers / Packaging: see list6
Formulation / Manufacturing:see details

Pharmacology for Ingredient: cytarabine

Clinical Trials for: cytarabine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd
CYTARABINE
cytarabine
INJECTABLE;INJECTION200914-001Dec 13, 2011RXNo<disabled><disabled>
Hospira
CYTARABINE
cytarabine
INJECTABLE;INJECTION071868-001Jun 4, 1990RXYes<disabled><disabled>
Teva Parenteral
CYTARABINE
cytarabine
INJECTABLE;INJECTION016793-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: cytarabine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc
DEPOCYT
cytarabine
INJECTABLE, LIPOSOMAL;INJECTION021041-001Apr 1, 19995,455,044<disabled>
Teva Parenteral
CYTARABINE
cytarabine
INJECTABLE;INJECTION016793-002Approved Prior to Jan 1, 19823,444,294<disabled>
Pacira Pharms Inc
DEPOCYT
cytarabine
INJECTABLE, LIPOSOMAL;INJECTION021041-001Apr 1, 19996,071,534<disabled>
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