Tacrolimus 4mg ER Tablet | Study Design

Tacrolimus ER Tablet – FDA – BE Study Design (NTI drug)

 

Regulatory Body FDA
Study Drug Information Test Product Reference Product
Strength Tacrolimus 4mg ENVARSUS XR 4mg
Formulation XR tablet XR tablet
Manufacturer Any Sponsor Rottendorf Pharma GmbH for Veloxis Pharmaceuticals
Route Oral Oral
Therapeutic Indication Therapeutic Indication: Immune Diseases Calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in de novo kidney transplant or kidney transplant patients converted from IR formulation to XR

 

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