Prograf

Prevents organ rejection. NDA 50709, held by Astellas. Tacrolimus.

As of Nov 13, 2026, NDA 50709 (Prograf), held by Astellas, was first approved by FDA on Apr 8, 1994, with 28 approved supplements and 0 published complete response letters.

First approved: Apr 8, 1994
Review: Priority
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Jul 16, 2021	Supplement 45Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 19, 2009	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Review Other Letter Label
Mar 29, 2006	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 1, 2000	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label
Apr 22, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 22, 1997	Supplement 5Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 8, 1994	Original applicationNew dosage form · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
PrografEQ 5MG BASE/ML · injectable;injection	Tacrolimus	RxReference drug

All 29 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 22, 2022	Supplement 47Labeling · Standard review	Approved	Letter Label Medication Guide
Jul 16, 2021	Supplement 45Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 30, 2020	Supplement 44Labeling · Standard review	Approved	Letter Label
Jun 11, 2019	Supplement 42Labeling · Standard review	Approved	Label
Dec 2, 2018	Supplement 41Labeling · Standard review	Approved	Letter Label
May 24, 2018	Supplement 40Labeling · Standard review	Approved	Label Letter
Jul 1, 2015	Supplement 37Manufacturing · Priority review	Approved	None posted
May 19, 2015	Supplement 38Labeling · Standard review	Approved	Letter Label
Sep 4, 2013	Supplement 36Labeling · Standard review	Approved	Letter Label
Aug 16, 2013	Supplement 35Manufacturing · Priority review	Approved	None posted
Aug 14, 2012	Supplement 34Labeling · Standard review	Approved	Letter Label
Jul 5, 2012	Supplement 33Labeling · Standard review	Approved	Label Letter
Feb 6, 2012	Supplement 31Labeling · Standard review	Approved	Letter Label
Jul 14, 2011	Supplement 30Labeling	Approved	Letter Label
Jul 14, 2011	Supplement 28Labeling · Standard review	Approved	Letter Label
May 19, 2009	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Review Other Letter Label
Feb 13, 2009	Supplement 26Labeling · Standard review	Approved	Label Letter
Apr 27, 2006	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 29, 2006	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 13, 2005	Supplement 18Labeling · Standard review	Approved	Letter
Jun 16, 2004	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 25, 2001	Supplement 12Labeling · Standard review	Approved	Label
Dec 1, 2000	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label
Apr 20, 1998	Supplement 7Manufacturing · Priority review	Approved	None posted
Apr 22, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 22, 1997	Supplement 5Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 25, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Jun 22, 1995	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 8, 1994	Original applicationNew dosage form · Priority review	Approved	Review

Identifiers

Application: NDA 50709
Drugs@FDA: Overview at FDA
Company: Astellas Pharma

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