FdaApplication
NDA 019734
Identifiers
- fda_app_no: NDA019734
Properties
| Property | Value |
|---|---|
| applicant_name | CHIESI USA INC |
| application_type | NDA |
| approval_date | 1992-01-30 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CARDENE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS |
| CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS |
| CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS |
| CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS |
5 products