Last Updated: September 24, 2026

Details for New Drug Application (NDA): 050722

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NDA 050722 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 050722

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

Pharmacology for NDA: 050722

Suppliers and Packaging for NDA: 050722

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELLCEPT	mycophenolate mofetil	CAPSULE;ORAL	050722	NDA	Genentech, Inc.	0004-0259	0004-0259-01	1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-01) / 100 CAPSULE in 1 BOTTLE, PLASTIC
CELLCEPT	mycophenolate mofetil	CAPSULE;ORAL	050722	NDA	Genentech, Inc.	0004-0259	0004-0259-43	1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-43) / 500 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	May 3, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050722

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CELLCEPT	mycophenolate mofetil	CAPSULE;ORAL	050722-001	May 3, 1995	4,753,935	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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