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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212161
Company: FOLDRX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VYNDAMAX TAFAMIDIS 61MG 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
05/03/2019 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD; 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, 212161Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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