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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Queensland Health
Dow
Argus Health
Covington
Moodys
Cerilliant
Boehringer Ingelheim

Generated: May 24, 2018

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 three 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:CELLCEPT
Applicant:Roche Palo
Ingredient:mycophenolate mofetil hydrochloride
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 N 0004-0298-09

Profile for product number 001

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

Expired US Patents for NDA 050758

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CELLCEPT mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 050758-001 Aug 12, 1998 ➤ Sign Up ➤ Sign Up
Roche Palo CELLCEPT mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 050758-001 Aug 12, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts
Teva
Johnson and Johnson
US Army
Farmers Insurance
Healthtrust
Colorcon
Baxter

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