APPLICATION
ANDA203897
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-02
LATEST ACTION
2025-08-28
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription
Products
PARICALCITOLDiscontinued
PARICALCITOL 0.002MG/ML (0.002MG/ML) · SOLUTION · INTRAVENOUS
PARICALCITOLPrescription
PARICALCITOL 0.005MG/ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
PARICALCITOLPrescription
PARICALCITOL 0.01MG/2ML (0.005MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-08-28Labeling · Supplement 5 · standardAP
2019-07-23Labeling · Supplement 4 · standardAP
2017-11-02UNKNOWN · OriginalAP
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.
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