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Details for Generic Name: tacrolimus

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Summary for Generic Name: tacrolimus

Tradenames:2
Patents:0
Applicants:1
NDAs:3
Drug Master File Entries: see list16
Suppliers: see list6
Therapeutic Class:Dermatological Agents

Pharmacology for Ingredient: tacrolimus

Tentative approvals for TACROLIMUS

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL0.75MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL1MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL4MG

Clinical Trials for: tacrolimus

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 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 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

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 Exclusivity Expiration
Astellas
PROGRAF
tacrolimus
INJECTABLE; INJECTION050709Apr 8, 1994RXYes<disabled><disabled>
Astellas
PROGRAF
tacrolimus
CAPSULE; ORAL050708Apr 8, 1994RXNo<disabled><disabled>
Astellas
PROGRAF
tacrolimus
CAPSULE; ORAL050708Aug 24, 1998RXNo<disabled><disabled>
Astellas
PROTOPIC
tacrolimus
OINTMENT; TOPICAL050777Dec 8, 2000RXNo<disabled><disabled>
Astellas
PROGRAF
tacrolimus
CAPSULE; ORAL050708Apr 8, 1994RXYes<disabled><disabled>
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