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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215498
Company: IPSEN

Products on NDA 215498

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BYLVAY	ODEVIXIBAT	0.2MG	CAPSULE, PELLETS;ORAL	Prescription	None	Yes	No
BYLVAY	ODEVIXIBAT	0.4MG	CAPSULE;ORAL	Prescription	None	Yes	No
BYLVAY	ODEVIXIBAT	0.6MG	CAPSULE, PELLETS;ORAL	Prescription	None	Yes	Yes
BYLVAY	ODEVIXIBAT	1.2MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215498

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215498s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215498Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215498Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215498s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215498Orig1s004ltr.pdf
06/13/2023	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215498s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215498Orig1s003ltr.pdf
10/21/2022	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215498s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215498Orig1s002ltr.pdf

Labels for NDA 215498

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2023	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215498s003lbl.pdf
05/08/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215498s004lbl.pdf
10/21/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215498s002lbl.pdf
07/20/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215498s000lbl.pdf

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