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Last Updated: January 19, 2020

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Details for New Drug Application (NDA): 091649

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NDA 091649 describes CAPECITABINE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Eugia Pharma, Hikma, Msn Labs Pvt Ltd, Mylan, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms Usa, and is included in ten NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 091649
Applicant:Teva Pharms Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 091649
Medical Subject Heading (MeSH) Categories for 091649
Suppliers and Packaging for NDA: 091649
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE capecitabine TABLET;ORAL 091649 ANDA Teva Pharmaceuticals USA, Inc. 0093-7473 0093-7473-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-7473-06)
CAPECITABINE capecitabine TABLET;ORAL 091649 ANDA Teva Pharmaceuticals USA, Inc. 0093-7474 0093-7474-89 120 TABLET, FILM COATED in 1 BOTTLE (0093-7474-89)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 16, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Sep 16, 2013TE:ABRLD:No

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