Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050709
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROGRAF TACROLIMUS EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/08/1994 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050709_prograf_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/02/2018 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050709s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050709s041ltr.pdf
05/24/2018 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210115Orig1s000,050708Orig1s047,050709Orig1s040ltr.pdf
05/19/2015 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050708Orig1s045,050709Orig1s038ltr.pdf
07/01/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/04/2013 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050708Orig1s043,050709Orig1s036ltr.pdf
08/16/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/14/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708Orig1s041,050709Orig1s034ltr.pdf
07/05/2012 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s040,050709s033ltr.pdf
02/06/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050709s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s038,050709s031ltr.pdf
07/14/2011 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf
07/14/2011 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf
02/13/2009 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s034,050709s026ltr.pdf
05/19/2009 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s027,050709s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050709Orig1s021_StatR.pdf
04/27/2006 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s026, 050709s020LTR.pdf
03/29/2006 SUPPL-19 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s024, 050709s019ltr.pdf
12/13/2005 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050708s025,050709s018ltr.pdf
06/16/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50708slr021,50709slr013ltr.pdf
07/25/2001 SUPPL-12 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s12lbl.pdf
12/01/2000 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf
04/20/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1997 SUPPL-6 Efficacy-New Indication

Label is not available on this site.

04/22/1997 SUPPL-5 Efficacy-New Dosing Regimen

Label is not available on this site.

04/25/1996 SUPPL-4 Labeling

Label is not available on this site.

06/22/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/02/2018 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050709s041lbl.pdf
05/24/2018 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf
05/19/2015 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf
09/04/2013 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf
08/14/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf
07/05/2012 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf
02/06/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050709s031lbl.pdf
07/14/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf
07/14/2011 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf
05/19/2009 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf
02/13/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf
04/27/2006 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf
06/16/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf
07/25/2001 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s12lbl.pdf
12/01/2000 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf

PROGRAF

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGRAF TACROLIMUS EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050709 ASTELLAS
TACROLIMUS TACROLIMUS EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203900 HOSPIRA INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English