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Last Updated: January 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090943

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NDA 090943 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 twenty 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. Twenty-one suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 090943
Formulation / Manufacturing:see details
Pharmacology for NDA: 090943
Medical Subject Heading (MeSH) Categories for 090943
Suppliers and Packaging for NDA: 090943
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE capecitabine TABLET;ORAL 090943 ANDA Mylan Pharmaceuticals Inc. 0378-2511 0378-2511-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2511-91)
CAPECITABINE capecitabine TABLET;ORAL 090943 ANDA Mylan Pharmaceuticals Inc. 0378-2512 0378-2512-78 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2512-78)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Aug 8, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 8, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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