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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208623
Company: AMICUS THERAP US

Products on NDA 208623

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208623

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
06/20/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208623Orig1s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208623Orig1s006,s007ltr.pdf
06/20/2023	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208623Orig1s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208623Orig1s006,s007ltr.pdf
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-Container/Carton Labels, Labeling-Package Insert	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-Container/Carton Labels, Labeling-Package Insert	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

Labels for NDA 208623

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/20/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208623Orig1s006s007lbl.pdf
06/20/2023	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208623Orig1s006s007lbl.pdf
06/20/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208623Orig1s006s007lbl.pdf
06/20/2023	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208623Orig1s006s007lbl.pdf
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208623s003lbl.pdf
09/25/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208623s003lbl.pdf
08/22/2019	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208623s001lbl.pdf
08/22/2019	SUPPL-1	Labeling-Package Insert	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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