APPLICATION
ANDA203289
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-14
LATEST ACTION
2017-06-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CALCITRIOLPrescription
CALCITRIOL 0.25MCG · CAPSULE · ORAL
CALCITRIOLPrescription
CALCITRIOL 0.5MCG · CAPSULE · ORAL
Approval history
2017-06-14UNKNOWN · 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.
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.