Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

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. 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
Paragraph IV (Patent) Challenges for 050759
Tradename Dosage Ingredient NDA Submissiondate
CELLCEPT SUSPENSION;ORAL mycophenolate mofetil 050759 2011-03-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength200MG/ML
Approval Date:Oct 1, 1998TE:ABRLD:Yes

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