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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 207652

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NDA 207652 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 207652

Tradename:	CAPECITABINE
Applicant:	Alkem Labs Ltd
Ingredient:	capecitabine
Patents:	0

Pharmacology for NDA: 207652

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 207652

Antimetabolites, Antineoplastic

Suppliers and Packaging for NDA: 207652

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAPECITABINE	capecitabine	TABLET;ORAL	207652	ANDA	Ascend Laboratories, LLC	67877-458	67877-458-12	120 TABLET, FILM COATED in 1 BOTTLE (67877-458-12)
CAPECITABINE	capecitabine	TABLET;ORAL	207652	ANDA	Ascend Laboratories, LLC	67877-458	67877-458-30	30 TABLET, FILM COATED in 1 BOTTLE (67877-458-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Nov 24, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 24, 2017	TE:	AB	RLD:	No

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