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Generated: November 15, 2018

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

The generic ingredient in CELLCEPT is mycophenolate mofetil hydrochloride. There are thirty-seven drug master file entries for this compound. Five 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
Formulation / Manufacturing:see details
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 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:RXDosage:SUSPENSION;ORALStrength200MG/ML
Approval Date:Oct 1, 1998TE:ABRLD:Yes

Expired US Patents for NDA 050759

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CELLCEPT mycophenolate mofetil SUSPENSION;ORAL 050759-001 Oct 1, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Roche Palo CELLCEPT mycophenolate mofetil SUSPENSION;ORAL 050759-001 Oct 1, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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