Drug application

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (NICARDIPINE HYDROCHLORIDE)

Drugs@FDA ANDA 220243 · CAPLIN

Key facts

Drug name NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Active ingredients NICARDIPINE HYDROCHLORIDE
Application type ANDA
Application number 220243
Company CAPLIN
Dosage forms INJECTABLE, INTRAVENOUS
Strength 20MG/200ML (0.1MG/ML)
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Oct 22, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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