APPLICATION
ANDA091108
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-27
LATEST ACTION
2014-10-17
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PARICALCITOLPrescription
PARICALCITOL 0.01MG/2ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
PARICALCITOLPrescription
PARICALCITOL 0.002MG/ML (0.002MG/ML) · SOLUTION · INTRAVENOUS
PARICALCITOLPrescription
PARICALCITOL 0.005MG/ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2014-10-17Manufacturing (CMC) · Supplement 1AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.