FdaApplication
NDA 213330
Identifiers
- fda_app_no: NDA213330
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA PHARMS |
| application_type | NDA |
| approval_date | 2020-11-09 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION;INTRAVENOUS |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION;INTRAVENOUS |
| LABETALOL HYDROCHLORIDE IN DEXTROSE | LABETALOL HYDROCHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION;INTRAVENOUS |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION;INTRAVENOUS |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION;INTRAVENOUS |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION;INTRAVENOUS |
6 products