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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214662
Company: MIRUM

Products on NDA 214662

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIVMARLI	MARALIXIBAT CHLORIDE	EQ 9.5MG BASE/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214662

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214662s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214662Orig1s000Corrected_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214662Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2024	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214662Orig1s005,s008ltr.pdf
03/13/2024	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214662Orig1s005,s008ltr.pdf
03/13/2023	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214662s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214662Orig1s004ltr.pdf
04/01/2022	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214662s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214662Orig1s001ltr.pdf

Labels for NDA 214662

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s005s008lbl.pdf
03/13/2024	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s005s008lbl.pdf
03/13/2023	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214662s004lbl.pdf
04/01/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214662s001lbl.pdf
09/29/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214662s000lbl.pdf

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