Application 210365
- Type
- NDA
- Sponsor
- GW RES LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPIDIOLEX | CANNABIDIOL | SOLUTION;ORAL | 100MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, LLC | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
| 70127-100 | Epidiolex | cannabidiol | Greenwich Biosciences, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82684 | SUPPL | 2025-06-27 |
| 82683 | SUPPL | 2025-06-27 |
| 82677 | SUPPL | 2025-06-27 |
| 77726 | SUPPL | 2024-03-06 |
| 77717 | SUPPL | 2024-03-05 |
| 75916 | SUPPL | 2023-10-24 |
| 75894 | SUPPL | 2023-10-24 |
| 70279 | SUPPL | 2022-02-28 |
| 70278 | SUPPL | 2022-02-28 |
| 70272 | SUPPL | 2022-02-28 |
| 68914 | ORIG | 2021-10-07 |
| 68870 | SUPPL | 2021-10-04 |
| 68869 | SUPPL | 2021-10-04 |
| 68859 | SUPPL | 2021-10-01 |
| 68858 | SUPPL | 2021-10-01 |
| 68857 | SUPPL | 2021-10-01 |
| 68779 | SUPPL | 2021-09-24 |
| 68738 | SUPPL | 2021-09-23 |
| 65018 | SUPPL | 2020-10-23 |
| 65017 | SUPPL | 2020-10-23 |
| 64994 | SUPPL | 2020-10-23 |
| 64176 | SUPPL | 2020-08-03 |
| 64175 | SUPPL | 2020-08-03 |
| 64174 | SUPPL | 2020-08-03 |
| 64166 | SUPPL | 2020-08-03 |
| 64165 | SUPPL | 2020-08-03 |
| 64164 | SUPPL | 2020-08-03 |
| 64163 | SUPPL | 2020-08-03 |
| 58198 | SUPPL | 2019-04-03 |
| 58197 | SUPPL | 2019-04-03 |
| 56914 | SUPPL | 2018-12-21 |
| 55018 | ORIG | 2018-07-27 |
| 54681 | ORIG | 2018-06-25 |
| 54680 | ORIG | 2018-06-25 |
| 54679 | ORIG | 2018-06-25 |