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Last Updated: December 28, 2025

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, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Hikma, MSN, Reliance Life, Rising, Shilpa, Sun Pharm, Teva Pharms Usa, and Teyro Labs, and is included in fourteen 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

Tradename:	CAPECITABINE
Applicant:	Rising
Ingredient:	capecitabine
Patents:	0

Medical Subject Heading (MeSH) Categories for 090943

Antimetabolites, Antineoplastic

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Aug 8, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Aug 8, 2014	TE:	AB	RLD:	No

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