← FDA DRUG APPROVALS

FDA ANDA · ANDA203978

NICARDIPINE HYDROCHLORIDE IN SODIUM CHLORIDE

nicardipine hydrochloride

Sponsor: INFORLIFE

APPLICATION
ANDA203978
TYPE
ANDA
ORIGINAL APPROVAL
2024-04-17
LATEST ACTION
2024-04-17
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) · INJECTABLE · INTRAVENOUS
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2024-04-17UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →