Application 212300
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | No | No |
| 002 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0641-6205 | Naloxone Hydrochloride | Naloxone Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |