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Details for Generic Name: tacrolimus

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Tacrolimus is the generic ingredient in two branded drugs marketed by Astellas, Accord Hlthcare, Dr Reddys Labs Ltd, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Watson Labs, and Fougera Pharms Inc, and is included in three NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for tacrolimus. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: tacrolimus

Drug Master File Entries: see list17
Suppliers: see list7
Therapeutic Class:Dermatological Agents

Pharmacology for Ingredient: tacrolimus

Tentative approvals for TACROLIMUS

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

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
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
INJECTABLE; INJECTION050709Apr 8, 1994RXYes<disabled><disabled>
OINTMENT; TOPICAL050777Dec 8, 2000RXNo<disabled><disabled>
OINTMENT; TOPICAL050777Dec 8, 2000RXYes<disabled><disabled>
CAPSULE; ORAL050708Apr 8, 1994RXYes<disabled><disabled>
CAPSULE; ORAL050708Aug 24, 1998RXNo<disabled><disabled>
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