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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 204668

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NDA 204668 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 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 204668

Tradename:	CAPECITABINE
Applicant:	Sun Pharm
Ingredient:	capecitabine
Patents:	0

Pharmacology for NDA: 204668

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 204668

Antimetabolites, Antineoplastic

Suppliers and Packaging for NDA: 204668

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAPECITABINE	capecitabine	TABLET;ORAL	204668	ANDA	Sun Pharmaceutical Industries, Inc.	62756-238	62756-238-18	1000 TABLET, FILM COATED in 1 BOTTLE (62756-238-18)
CAPECITABINE	capecitabine	TABLET;ORAL	204668	ANDA	Sun Pharmaceutical Industries, Inc.	62756-238	62756-238-86	60 TABLET, FILM COATED in 1 BOTTLE (62756-238-86)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jun 21, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 21, 2019	TE:		RLD:	No

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