Last Updated: September 28, 2026

Details for New Drug Application (NDA): 050758

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NDA 050758 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 050758

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

Pharmacology for NDA: 050758

Suppliers and Packaging for NDA: 050758

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758	NDA	Genentech, Inc.	0004-0298	0004-0298-09	4 VIAL in 1 CARTON (0004-0298-09) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Aug 12, 1998	TE:	AP	RLD:	Yes

Expired US Patents for NDA 050758

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	⤷ Start Trial	⤷ Start Trial
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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