approval · primary record
NICARDIPINE HYDROCHLORIDE
2 approval events · latest 2026-03-27
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-03-27 |
| Approval events | 2 |
| Brand | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER |
| Sponsor | CHIESI |
| Route | INTRAVENOUS |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-03-27 | FDA | NDA | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | CHIESI | INTRAVENOUS |
| 2025-06-27 | FDA | NDA | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | HIKMA INTL PHARMS | INTRAVENOUS |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:32:14.998Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:nicardipine-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Nicardipine Hydrochloride · compound