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Serving leading biopharmaceutical companies globally:

Argus Health
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050758

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NDA 050758 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-six 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 050758

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050758

Suppliers and Packaging for NDA: 050758

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELLCEPT mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 050758 NDA Genentech, Inc. 0004-0298 0004-0298-09 4 VIAL in 1 CARTON (0004-0298-09) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Aug 12, 1998TE:APRLD:Yes

Expired Orange Book Patents for NDA: 050758

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche PaloCELLCEPTmycophenolate mofetil hydrochlorideINJECTABLE;INJECTION050758-001Aug 12, 1998► Subscribe► Subscribe
Roche PaloCELLCEPTmycophenolate mofetil hydrochlorideINJECTABLE;INJECTION050758-001Aug 12, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Express Scripts
Covington
Teva
Baxter
Cipla
Harvard Business School
Citi
Chinese Patent Office
US Department of Justice
Johnson and Johnson

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