← FDA DRUG APPROVALS

FDA NDA · NDA205917

PARICALCITOL

Sponsor: HIKMA PHARMS

APPLICATION
NDA205917
TYPE
NDA
ORIGINAL APPROVAL
2014-11-18
LATEST ACTION
2026-06-17
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PARICALCITOLDiscontinued
PARICALCITOL 0.005MG/ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
PARICALCITOLDiscontinued
PARICALCITOL 0.01MG/2ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
PARICALCITOLDiscontinued
PARICALCITOL 0.002MG/ML (0.002MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-06-17Labeling · Supplement 3 · standard — Letter ↗AP
2014-11-18Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →