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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213969
Company: EIGER BIOPHARMS

Products on NDA 213969

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOKINVY	LONAFARNIB	50MG	CAPSULE;ORAL	Prescription	None	Yes	No
ZOKINVY	LONAFARNIB	75MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213969

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213969s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213969Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213969Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213969s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213969Orig1s002, s003ltr.pdf
03/21/2024	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213969s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213969Orig1s002, s003ltr.pdf

Labels for NDA 213969

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213969s002s003lbl.pdf
03/21/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213969s002s003lbl.pdf
11/20/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213969s000lbl.pdf

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