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Last Updated: March 28, 2024

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 thirty-eight drug master file entries for this compound. Twelve 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
Formulation / Manufacturing:see details
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:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 19, 1997TE:ABRLD:Yes

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