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Generated: November 21, 2017

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, Mylan Labs Ltd, Mylan Pharms Inc, Hospira, West-ward Pharms Int, and Teva Parenteral, and is included in thirteen 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. Six suppliers are listed for this compound. Additional details are available on the cytarabine profile page.

Summary for 016793

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 016793

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 016793

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Parenteral
CYTARABINE
cytarabine
INJECTABLE;INJECTION016793-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Teva Parenteral
CYTARABINE
cytarabine
INJECTABLE;INJECTION016793-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Accenture
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Daiichi Sankyo
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US Army
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Boehringer Ingelheim
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US Department of Justice

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