Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050708
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROGRAF TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription AB Yes No
PROGRAF TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription AB Yes Yes
PROGRAF TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription AB Yes No
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 1 - New Molecular Entity PRIORITY; Orphan Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050708_prograf_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/02/2018 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050708s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050708s048ltr.pdf
05/24/2018 SUPPL-47 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-45 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
03/19/2014 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

09/04/2013 SUPPL-43 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
01/28/2013 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

08/14/2012 SUPPL-41 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-40 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-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s038,050709s031ltr.pdf
07/14/2011 SUPPL-37 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-36 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-34 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-27 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/2009/050708Orig1s027_StatR.pdf
04/27/2006 SUPPL-26 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
12/13/2005 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050708s025,050709s018ltr.pdf
03/29/2006 SUPPL-24 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s024, 050709s019ltr.pdf
06/16/2004 SUPPL-21 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
10/24/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/2001 SUPPL-16 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf
07/25/2001 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf
05/08/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/01/2000 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s13lbl.pdf
08/24/1998 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/24/1998 SUPPL-10 Manufacturing (CMC)-Control Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf
04/20/1998 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1997 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

04/22/1997 SUPPL-7 Efficacy-New Dosing Regimen

Label is not available on this site.

04/25/1996 SUPPL-6 Labeling

Label is not available on this site.

06/22/1995 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/22/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

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

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-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050708s048lbl.pdf
05/24/2018 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf
05/19/2015 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf
09/04/2013 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf
08/14/2012 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf
07/05/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf
02/06/2012 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s038lbl.pdf
07/14/2011 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf
07/14/2011 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf
05/19/2009 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf
02/13/2009 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf
04/27/2006 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf
06/16/2004 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf
07/25/2001 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf
07/25/2001 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf
12/01/2000 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s13lbl.pdf
08/24/1998 SUPPL-10 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf

PROGRAF

CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGRAF TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription Yes AB 050708 ASTELLAS
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 091195 ACCORD HLTHCARE
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER PHARMS LLC
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 090509 DR REDDYS LABS LTD
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 090596 MYLAN
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 090802 PANACEA BIOTEC LTD
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 065461 SANDOZ
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 090687 STRIDES PHARMA

CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGRAF TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription Yes AB 050708 ASTELLAS
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 091195 ACCORD HLTHCARE
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER PHARMS LLC
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090509 DR REDDYS LABS LTD
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090596 MYLAN
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090802 PANACEA BIOTEC LTD
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 065461 SANDOZ
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090687 STRIDES PHARMA

CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGRAF TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription Yes AB 050708 ASTELLAS
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 091195 ACCORD HLTHCARE
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER PHARMS LLC
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 090509 DR REDDYS LABS LTD
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 090596 MYLAN
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 090802 PANACEA BIOTEC LTD
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 065461 SANDOZ
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 090687 STRIDES PHARMA

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