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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210365
Company: JAZZ PHARMS RES

Medication Guide

Products on NDA 210365

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPIDIOLEX	CANNABIDIOL	100MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210365

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
06/25/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice of DEA Scheduling; Date of Approval – September 28, 2018

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
03/04/2024	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)
10/20/2023	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)
02/24/2022	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)
09/30/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)
09/30/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)
08/26/2021	SUPPL-11		Label (PDF) Letter (PDF)
10/22/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)
07/31/2020	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)
07/31/2020	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)
07/31/2020	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)
05/22/2019	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
12/12/2018	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)

Labels for NDA 210365

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
03/04/2024	SUPPL-21	Labeling-Package Insert	Label (PDF)
03/04/2024	SUPPL-21	Labeling-Medication Guide	Label (PDF)
10/20/2023	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF)
02/24/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)
09/30/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)
09/30/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)
08/26/2021	SUPPL-11	Manufacturing (CMC)	Label (PDF)
10/22/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)
07/31/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)
07/31/2020	SUPPL-7	Labeling-Medication Guide	Label (PDF)
07/31/2020	SUPPL-6	Efficacy-New Indication	Label (PDF)
07/31/2020	SUPPL-5	Efficacy-New Indication	Label (PDF)
12/12/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)
12/12/2018	SUPPL-2	Labeling-Medication Guide	Label (PDF)
12/12/2018	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)
06/25/2018	ORIG-1	Approval	Label (PDF)

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