Drugs@FDA: FDA-Approved Drugs

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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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/16/2021 SUPPL-53 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050708s053,050709s045,210115s005lbl.pdf
12/30/2020 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050708s052,050709s044,210115s004lbl.pdf
06/11/2019 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050708s050,050709s042,210115s002lbl.pdf
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

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