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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Cantor Fitzgerald
Johnson and Johnson
Federal Trade Commission

Generated: June 24, 2017

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 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. Three suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for NDA: 050759

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
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 050759

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
mycophenolate mofetil
SUSPENSION;ORAL050759-001Oct 1, 19984,753,935► Subscribe
Roche Palo
mycophenolate mofetil
SUSPENSION;ORAL050759-001Oct 1, 19985,688,529► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Argus Health
US Department of Justice
US Army
Chinese Patent Office
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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