FdaApplication
ANDA 219334
Identifiers
- fda_app_no: ANDA219334
Properties
| Property | Value |
|---|---|
| applicant_name | FRESENIUS KABI USA LLC |
| application_type | ANDA |
| approval_date | 2026-08-04 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS |
2 products