Application 076573
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
| 002 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1371 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1371 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1371 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 63323-652 | Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-652 | Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |