Details for New Drug Application (NDA): 050759

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NDA 050759 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 thirty-eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 050759

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

Pharmacology for NDA: 050759

Suppliers and Packaging for NDA: 050759

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759	NDA	Genentech, Inc.	0004-0261	0004-0261-29	1 BOTTLE, PLASTIC in 1 CARTON (0004-0261-29) / 225 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/ML
Approval Date:	Oct 1, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050759

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998	⤷ Sign Up	⤷ Sign Up
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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