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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211996
Company: FOLDRX PHARMS

Products on NDA 211996

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VYNDAQEL	TAFAMIDIS MEGLUMINE	20MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211996

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211996s000,212161s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211996Orig1s000, 212161Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211996Orig1s000,%20212161Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/17/2023	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211996s002,212161s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211996Orig1s002; 212161Orig1s002ltr.pdf
06/01/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211996s001,212161s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211996Orig1s001;212161Orig1s001ltr.pdf

Labels for NDA 211996

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/17/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211996s002,212161s002lbl.pdf
06/01/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211996s001,212161s001lbl.pdf
05/03/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211996s000,212161s000lbl.pdf

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