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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204096
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASTAGRAF XL TACROLIMUS EQ 0.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
ASTAGRAF XL TACROLIMUS EQ 1MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
ASTAGRAF XL TACROLIMUS EQ 5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None 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
07/19/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204096Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204096Orig1s000OTOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/22/2022 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050708Orig1s054; 050709Orig1s047; 210115Orig1s006; 204096Orig1s010ltr.pdf
12/30/2020 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204096s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204096Orig1s009ltr.pdf
06/11/2019 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204096s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204096Orig1s007ltr.pdf
11/29/2018 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204096s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204096Orig1s005ltr.pdf
12/16/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr.pdf
12/16/2015 SUPPL-3 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr.pdf
02/28/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204096s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s002ltr.pdf
02/11/2014 SUPPL-1 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/22/2022 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf
12/30/2020 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204096s009lbl.pdf
06/11/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204096s007lbl.pdf
11/29/2018 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204096s005lbl.pdf
12/16/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf
12/16/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf
12/16/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf
02/28/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204096s002lbl.pdf
07/19/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096s000lbl.pdf
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