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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 four suppliers. Additional details are available on the CELLCEPT profile page.

The generic ingredient in CELLCEPT is mycophenolate mofetil hydrochloride. There are thirty-five drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for NDA: 050723

Roche Palo
mycophenolate mofetil

Pharmacology for NDA: 050723

Suppliers and Packaging for NDA: 050723

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 19, 1997TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 050723

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
mycophenolate mofetil
TABLET;ORAL050723-001Jun 19, 19974,753,935<disabled>
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