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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Army
Cerilliant
Healthtrust
Citi
Moodys
AstraZeneca
UBS
McKinsey

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090943

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NDA 090943 describes CAPECITABINE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Mylan Pharms Inc, Shilpa Medicare Ltd, Teva Pharms Usa, and West-ward Pharms Int, and is included in seven NDAs. It is available from fourteen suppliers. Additional details are available on the CAPECITABINE profile page.

The generic ingredient in CAPECITABINE is capecitabine. There are twenty-eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 090943
Tradename:CAPECITABINE
Applicant:Mylan Pharms Inc
Ingredient:capecitabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090943
Medical Subject Heading (MeSH) Categories for 090943
Suppliers and Packaging for NDA: 090943
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE capecitabine TABLET;ORAL 090943 ANDA KAISER FOUNDATION HOSPITALS 0179-0195 N 0179-0195-70
CAPECITABINE capecitabine TABLET;ORAL 090943 ANDA Mylan Pharmaceuticals Inc. 0378-2511 N 0378-2511-91

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Aug 8, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 8, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Fuji
Cipla
US Army
Dow
Johnson and Johnson
US Department of Justice
QuintilesIMS
AstraZeneca

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