Last Updated: September 24, 2026

Details for New Drug Application (NDA): 050723

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NDA 050723 describes CELLCEPT, which is a drug marketed by Roche Palo and is included in four NDAs. It is available from one supplier. Additional details are available on the CELLCEPT profile page.

The generic ingredient in CELLCEPT is mycophenolate mofetil hydrochloride. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 050723

Tradename:	CELLCEPT
Applicant:	Roche Palo
Ingredient:	mycophenolate mofetil
Patents:	0

Pharmacology for NDA: 050723

Suppliers and Packaging for NDA: 050723

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELLCEPT	mycophenolate mofetil	TABLET;ORAL	050723	NDA	Genentech, Inc.	0004-0260	0004-0260-01	1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
CELLCEPT	mycophenolate mofetil	TABLET;ORAL	050723	NDA	Genentech, Inc.	0004-0260	0004-0260-43	1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-43) / 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 19, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050723

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CELLCEPT	mycophenolate mofetil	TABLET;ORAL	050723-001	Jun 19, 1997	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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