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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208623
Company: AMICUS THERAP US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GALAFOLD MIGALASTAT HYDROCHLORIDE EQ 123MG BASE CAPSULE;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
08/10/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208623Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208623Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/10/2021 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208623s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208623Orig1s005ltr.pdf
09/25/2020 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208623s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208623Orig1s003ltr.pdf
08/22/2019 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208623s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208623Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/10/2021 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208623s005lbl.pdf
09/25/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208623s003lbl.pdf
09/25/2020 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208623s003lbl.pdf
08/22/2019 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208623s001lbl.pdf
08/22/2019 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208623s001lbl.pdf
08/10/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf
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