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Details for Generic Name: mycophenolate mofetil hydrochloride

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Mycophenolate mofetil hydrochloride is the generic ingredient in one branded drug marketed by Roche Palo and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty-three drug master file entries for mycophenolate mofetil hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: mycophenolate mofetil hydrochloride

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list33
Suppliers: see list1

Pharmacology for Ingredient: mycophenolate mofetil hydrochloride

Tentative approvals for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION500MG

Clinical Trials for: mycophenolate mofetil hydrochloride

Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
Status: Terminated Condition: Stable Renal Transplant Recipients

Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Status: Completed Condition: Autoimmune Disease

A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . .
Status: Terminated Condition: Interstitial Cystitis; Painful Bladder Syndrome

Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
Status: Completed Condition: Systemic Lupus Erythematosus; Arthritis

Influence of Pantoprazole to the Bioavailability of Myfortic® and CellCept®
Status: Recruiting Condition: Immunosuppressive Medication After Renal Transplantation; Concomitant Medication After Renal Transplantation

A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS)
Status: Not yet recruiting Condition: Renal Transplantation

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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 hydrochloride
INJECTABLE;INJECTION050758Aug 12, 1998RXYes5,543,408<disabled>Y<disabled>
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