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Profile for Tradename: PROGRAF

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Prograf is a drug marketed by Astellas and is included in two NDAs. It is available from four suppliers.

The generic ingredient in PROGRAF is tacrolimus. There are seventeen drug master file entries for this compound. Seven suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the tacrolimus profile page.

Summary for Tradename: PROGRAF

Patents:0
Applicants:1
NDAs:2
Suppliers: see list4

Pharmacology for Tradename: PROGRAF

Clinical Trials for: PROGRAF

A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
Status: Recruiting Condition: Liver Transplantation

A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
Status: Recruiting Condition: Renal Transplantation

A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
Status: Recruiting Condition: Liver Transplantation

Prograf-Advagraf Cross Over Conversion Study
Status: Completed Condition: Kidney-Pancreas Transplantation

A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
Status: Completed Condition: Liver Transplantation

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
Status: Completed Condition: Liver Transplantation

A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF
Status: Completed Condition: Kidney Transplantation

A Phase 2 Double-Blind, Double-dummy, Multicenter, Prospective, Randomized Study of the Pharmacokinetics of LCP-Tacro Tablets, Once-Daily, Compared to Prograf Capsules, Twice-daily, for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
Status: Completed Condition: Renal Failure

Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients
Status: Completed Condition: Kidney Transplantation; Renal Transplantation

Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
Status: Completed Condition: Renal Transplant

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
Astellas
PROGRAF
tacrolimus
CAPSULE;ORAL050708Aug 24, 1998RXNo<disabled><disabled>
Astellas
PROGRAF
tacrolimus
INJECTABLE;INJECTION050709Apr 8, 1994RXYes<disabled><disabled>
Astellas
PROGRAF
tacrolimus
CAPSULE;ORAL050708Apr 8, 1994RXNo<disabled><disabled>
Astellas
PROGRAF
tacrolimus
CAPSULE;ORAL050708Apr 8, 1994RXYes<disabled><disabled>
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