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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200483

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NDA 200483 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 200483
Applicant:West-ward Pharms Int
Formulation / Manufacturing:see details
Pharmacology for NDA: 200483
Medical Subject Heading (MeSH) Categories for 200483
Suppliers and Packaging for NDA: 200483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE capecitabine TABLET;ORAL 200483 ANDA West-Ward Pharmaceuticals Corp. 0054-0271 N 0054-0271-21
CAPECITABINE capecitabine TABLET;ORAL 200483 ANDA West-Ward Pharmaceuticals Corp. 0054-0272 N 0054-0272-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 14, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 14, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission
Daiichi Sankyo

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