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Generated: November 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050722

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NDA 050722 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 050722

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

Pharmacology for NDA: 050722

Suppliers and Packaging for NDA: 050722

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELLCEPT
mycophenolate mofetil
CAPSULE;ORAL 050722 NDA Genentech, Inc. 0004-0259 0004-0259-01 1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-01) > 100 CAPSULE in 1 BOTTLE, PLASTIC
CELLCEPT
mycophenolate mofetil
CAPSULE;ORAL 050722 NDA Genentech, Inc. 0004-0259 0004-0259-05 12 BOTTLE, PLASTIC in 1 CARTON (0004-0259-05) > 120 CAPSULE in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:May 3, 1995TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 050722

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CELLCEPT
mycophenolate mofetil
CAPSULE;ORAL050722-001May 3, 1995► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

UBS
Colorcon
Fish and Richardson
Citi
Accenture
Queensland Health
Cipla
Healthtrust
Mallinckrodt
Merck

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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