Application 215457
- Type
- NDA
- Sponsor
- KALEO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60842-002 | Naloxone Hydrochloride Injection, USP, Auto-Injector | Naloxone Hydrochloride | Kaleo, Inc. | NDA | Current |