Skip to contentApplication 212045
- Type
- NDA
- Sponsor
- HIKMA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KLOXXADO | NALOXONE HYDROCHLORIDE | SPRAY;NASAL | 8MG | No | No |
| 002 | KLOXXADO | NALOXONE HYDROCHLORIDE | SPRAY;NASAL | 4MG/SPRAY | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59467-679 | KLOXXADO | Naloxone HCL | Hikma Specialty USA Inc. | NDA | Current |
| 59467-679 | KLOXXADO | Naloxone HCL | Hikma Specialty USA Inc. | NDA | Current |
| 59467-679 | KLOXXADO | Naloxone HCL | Hikma Specialty USA Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83211 | SUPPL | 2025-08-27 |
| 83197 | SUPPL | 2025-08-26 |
| 68889 | ORIG | 2021-10-05 |
| 67307 | ORIG | 2021-04-30 |
| 67279 | ORIG | 2021-04-30 |