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Last Updated: August 6, 2020

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Details for New Drug Application (NDA): 207456

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NDA 207456 describes CAPECITABINE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Eugia Pharma, Hikma, MSN, Mylan, Reliance Life, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms Usa, and is included in eleven NDAs. It is available from seventeen 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 207456
Tradename:CAPECITABINE
Applicant:Shilpa Medicare Ltd
Ingredient:capecitabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207456
Medical Subject Heading (MeSH) Categories for 207456
Suppliers and Packaging for NDA: 207456
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE capecitabine TABLET;ORAL 207456 ANDA Areva Pharmaceuticals 59923-721 59923-721-60 60 TABLET, FILM COATED in 1 BOTTLE (59923-721-60)
CAPECITABINE capecitabine TABLET;ORAL 207456 ANDA Areva Pharmaceuticals 59923-722 59923-722-12 120 TABLET, FILM COATED in 1 BOTTLE (59923-722-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 12, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 12, 2016TE:ABRLD:No

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