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CELLCEPT Drug Profile

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Cellcept is a drug marketed by Roche Palo and is included in four NDAs. It is available from four suppliers.

The generic ingredient in CELLCEPT is mycophenolate mofetil hydrochloride. There are thirty-five drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for Tradename: CELLCEPT

Patents:0
Applicants:1
NDAs:4
Suppliers / Packagers: see list4

Pharmacology for Tradename: CELLCEPT

Clinical Trials for: CELLCEPT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo
CELLCEPT
mycophenolate mofetil
CAPSULE;ORAL050722-001May 3, 1995RXYes<disabled><disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil
SUSPENSION;ORAL050759-001Oct 1, 1998RXYes<disabled><disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil
TABLET;ORAL050723-001Jun 19, 1997RXYes<disabled><disabled>
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Expired Patents for Tradename: CELLCEPT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CELLCEPT
mycophenolate mofetil
CAPSULE;ORAL050722-001May 3, 19954,753,935<disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil
SUSPENSION;ORAL050759-001Oct 1, 19984,753,935<disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION050758-001Aug 12, 19984,753,935<disabled>
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Paragraph IV activity for: CELLCEPT

Drugname Dosage Strength RLD Submissiondate
mycophenolic mofetilFor Oral Suspension200 mg/mLCellcept3/25/2011
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