← FDA Drug Approvals (Drugs@FDA)

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2026-08-04

Drug application

FDA Application #
ANDA219334
Application type
Abbreviated New Drug Application (Generic)
Brand name
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Generic name
Nicardipine Hydrochloride
Active ingredients
NICARDIPINE HYDROCHLORIDE
Dosage form
INJECTABLE
Route
INTRAVENOUS
Marketing status
Prescription
Sponsor
FRESENIUS KABI USA
First approval
2026-08-04

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown