Prevents organ rejection. NDA 210115, held by Astellas. Tacrolimus.
As of Nov 14, 2026, NDA 210115 (Prograf), held by Astellas, was first approved by FDA on May 24, 2018, with 6 approved supplements and 0 published complete response letters.
PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant PROGRAF is indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant, liver transplant, heart transplant, or lung transplant in combination with other immunosuppressants.
| Jul 16, 2021 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| May 24, 2018 | Original applicationNew dosage form · Standard review | Approved |
| PrografEQ 0.2MG BASE/PACKET · for suspension;oral | Tacrolimus | RxReference drug |
| PrografEQ 1MG BASE/PACKET · for suspension;oral | Tacrolimus | RxReference drug |
| Sep 14, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Nov 22, 2022 | Supplement 6Labeling · Standard review | Approved | |
| Jul 16, 2021 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Dec 30, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Jun 11, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Dec 2, 2018 | Supplement 1Labeling · Standard review | Approved | |
| May 24, 2018 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
