tacrolimus
Drug Details
- Generic Name
- tacrolimus
- Brand Names
- Tacrolimus, tacrolimus
- Application Number
- ANDA200744
- Sponsor
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- NDC Codes
- 10
- Dosage Forms
- OINTMENT, CAPSULE, POWDER
- Routes
- TOPICAL, ORAL
- Active Ingredients
- TACROLIMUS
Indications and Usage
1.1 Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplant [see Clinical Studies (14.2)], and heart transplant [see Clinical Studies (14.3)], and pediatric patients receiving allogeneic liver transplants [see Clinical Studies (14.2)] in combination with other immunosuppressants. Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.