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Chinese Patent Office
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US Army
Healthtrust

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016793

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NDA 016793 describes CYTARABINE, which is a drug marketed by Fresenius Kabi Usa, Hong Kong, Hospira, Mylan Labs Ltd, Teva Parenteral, and West-ward Pharms Int, and is included in fourteen NDAs. It is available from four 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 016793

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 21, 1987TE:RLD:Yes

Expired US Patents for NDA 016793

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 ➤ Sign Up ➤ Sign Up
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Dow
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