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Generated: May 24, 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, Eugia Pharma, Mylan Pharms Inc, Shilpa Medicare Ltd, Teva Pharms Usa, and West-ward Pharms Int, and is included in eight NDAs. It is available from fifteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 200483
Tradename:CAPECITABINE
Applicant:West-ward Pharms Int
Ingredient:capecitabine
Patents:0
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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