Details for New Drug Application (NDA): 020896

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NDA 020896 describes XELODA, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from two suppliers. Additional details are available on the XELODA profile page.

The generic ingredient in XELODA is capecitabine. There are twenty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the capecitabine profile page.

Summary for 020896

Tradename:	XELODA
Applicant:	Cheplapharm
Ingredient:	capecitabine
Patents:	0

Pharmacology for NDA: 020896

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 020896

Antimetabolites, Antineoplastic

Suppliers and Packaging for NDA: 020896

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XELODA	capecitabine	TABLET;ORAL	020896	NDA	Genentech, Inc.	0004-1100	0004-1100-20	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1100-20)
XELODA	capecitabine	TABLET;ORAL	020896	NDA	Genentech, Inc.	0004-1101	0004-1101-50	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1101-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Apr 30, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 30, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020896

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998	⤷ Sign Up	⤷ Sign Up
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	⤷ Sign Up	⤷ Sign Up
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998	⤷ Sign Up	⤷ Sign Up
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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