Last Updated: September 24, 2026

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, 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 eighteen suppliers. Additional details are available on the CAPECITABINE profile page.

The generic ingredient in CAPECITABINE is capecitabine. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.

Summary for 200483

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

Medical Subject Heading (MeSH) Categories for 200483

Antimetabolites, Antineoplastic

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jul 14, 2016	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 14, 2016	TE:		RLD:	No

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