Application 214697
- Type
- NDA
- Sponsor
- ARS PHARMS OPERATION
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NEFFY | EPINEPHRINE | SPRAY;NASAL | 2MG/SPRAY | Yes | Yes |
| 002 | NEFFY | EPINEPHRINE | SPRAY;NASAL | 1MG/SPRAY | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85567 | SUPPL | 2026-04-10 |
| 81445 | SUPPL | 2026-04-07 |
| 85566 | SUPPL | 2026-03-30 |
| 85177 | SUPPL | 2026-02-27 |
| 83945 | SUPPL | 2025-10-28 |
| 83937 | SUPPL | 2025-10-27 |
| 81950 | ORIG | 2025-04-11 |
| 81459 | SUPPL | 2025-03-06 |
| 79374 | ORIG | 2024-08-12 |
| 79366 | ORIG | 2024-08-12 |