Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 210365
Company: GW RES LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPIDIOLEX CANNABIDIOL 100MG/ML SOLUTION;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
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 18, 2018
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note
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-Medication Guide, Labeling-Package Insert 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-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
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-Medication Guide Label (PDF)
07/31/2020 SUPPL-7 Labeling-Package Insert 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-Container/Carton Labels Label (PDF)
12/12/2018 SUPPL-2 Labeling-Medication Guide Label (PDF)
12/12/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
06/25/2018 ORIG-1 Approval Label (PDF)

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English