Application 209963
- Type
- NDA
- Sponsor
- GENUS LIFESCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GOPRELTO | COCAINE HYDROCHLORIDE | SOLUTION;NASAL | 4% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 64950-359 | GOPRELTO | cocaine hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-359 | GOPRELTO | cocaine hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-362 | cocaine hydrochloride | cocaine hydrochloride | Genus Lifesciences Inc. | NDA AUTHORIZED GENERIC | Current |
| 64950-362 | cocaine hydrochloride | cocaine hydrochloride | Genus Lifesciences Inc. | NDA AUTHORIZED GENERIC | Current |
| 64950-362 | cocaine hydrochloride | cocaine hydrochloride | Genus Lifesciences Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74801 | SUPPL | 2023-07-20 |
| 74785 | SUPPL | 2023-07-19 |
| 72761 | SUPPL | 2022-12-01 |
| 72747 | SUPPL | 2022-11-29 |
| 55385 | ORIG | 2018-09-05 |
| 53874 | ORIG | 2018-04-30 |
| 50780 | ORIG | 2017-12-20 |