Prograf

Prevents organ rejection. NDA 50708, held by Astellas. Tacrolimus.

As of Nov 14, 2026, NDA 50708 (Prograf), held by Astellas, was first approved by FDA on Apr 8, 1994, with 36 approved supplements and 0 published complete response letters.

First approved: Apr 8, 1994
Review: Priority
Supplements approved: 36
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 37 submissions below


Jul 16, 2021	Supplement 53Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 19, 2009	Supplement 27Efficacy (new indication or use)	Approved	Review Other Letter Label
Mar 29, 2006	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 1, 2000	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label
Apr 22, 1997	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 22, 1997	Supplement 8Efficacy (new indication or use)	Approved	None posted
Apr 8, 1994	Original applicationNew molecular entity · Priority review	Approved	Review

Products

3 strengths and forms


PrografEQ 1MG BASE · capsule;oral	Tacrolimus	RxReference drug
PrografEQ 5MG BASE · capsule;oral	Tacrolimus	RxReference drug
PrografEQ 0.5MG BASE · capsule;oral	Tacrolimus	RxReference drug

All 37 submissions, including labeling and manufacturing supplements


Sep 14, 2023	Supplement 55Labeling · Standard review	Approved	Letter Label
Nov 22, 2022	Supplement 54Labeling · Standard review	Approved	Letter Label Medication Guide
Jul 16, 2021	Supplement 53Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 30, 2020	Supplement 52Labeling · Standard review	Approved	Letter Label
Jun 11, 2019	Supplement 50Labeling · Standard review	Approved	Label
Dec 2, 2018	Supplement 48Labeling · Standard review	Approved	Letter Label
May 24, 2018	Supplement 47Labeling · Standard review	Approved	Label Letter
May 19, 2015	Supplement 45Labeling · Standard review	Approved	Label Letter
Mar 19, 2014	Supplement 44Manufacturing · Priority review	Approved	None posted
Sep 4, 2013	Supplement 43Labeling · Standard review	Approved	Label Letter
Jan 28, 2013	Supplement 42Manufacturing · Priority review	Approved	None posted
Aug 14, 2012	Supplement 41Labeling · Standard review	Approved	Letter Label
Jul 5, 2012	Supplement 40Labeling · Standard review	Approved	Label Letter
Feb 6, 2012	Supplement 38Labeling · Standard review	Approved	Letter Label
Jul 14, 2011	Supplement 37Labeling · Standard review	Approved	Letter Label
Jul 14, 2011	Supplement 36Labeling · Standard review	Approved	Letter Label
May 19, 2009	Supplement 27Efficacy (new indication or use)	Approved	Review Other Letter Label
Feb 13, 2009	Supplement 34Labeling · Standard review	Approved	Label Letter
Apr 27, 2006	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 29, 2006	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 13, 2005	Supplement 25Labeling · Standard review	Approved	Letter
Jun 16, 2004	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 24, 2002	Supplement 17Manufacturing · Priority review	Approved	None posted
Jul 25, 2001	Supplement 15Labeling · Standard review	Approved	Label
Jul 25, 2001	Supplement 16Labeling · Standard review	Approved	Label
May 8, 2001	Supplement 14Manufacturing · Priority review	Approved	None posted
Dec 1, 2000	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label
Aug 24, 1998	Supplement 10Manufacturing · Priority review	Approved	Label
Aug 24, 1998	Supplement 11Manufacturing · Priority review	Approved	None posted
Apr 20, 1998	Supplement 9Manufacturing · Priority review	Approved	None posted
Apr 22, 1997	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 22, 1997	Supplement 8Efficacy (new indication or use)	Approved	None posted
Apr 25, 1996	Supplement 6Labeling · Standard review	Approved	None posted
Jun 22, 1995	Supplement 3Manufacturing · Priority review	Approved	None posted
Jun 22, 1995	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 22, 1995	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 8, 1994	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 50708
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