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NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CAPLIN · Approved 2025-10-22

Drug application

FDA Application #
ANDA220243
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
CAPLIN
Manufacturer
Caplin Steriles Limited
First approval
2025-10-22

Source

Authoritative
Drugs@FDA application overview
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