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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
Dow
Teva
UBS
Covington
McKinsey
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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202593

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NDA 202593 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 202593
Tradename:CAPECITABINE
Applicant:Accord Hlthcare
Ingredient:capecitabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202593
Medical Subject Heading (MeSH) Categories for 202593
Suppliers and Packaging for NDA: 202593
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE capecitabine TABLET;ORAL 202593 ANDA Northstar RxLLC 16714-467 N 16714-467-01
CAPECITABINE capecitabine TABLET;ORAL 202593 ANDA Northstar RxLLC 16714-468 N 16714-468-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Apr 23, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 23, 2015TE:ABRLD:No

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Argus Health
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