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FDA ANDA · ANDA091356

CALCITRIOL

Sponsor: ONESOURCE SPECIALTY

APPLICATION
ANDA091356
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-12
LATEST ACTION
2014-12-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CALCITRIOLPrescription
CALCITRIOL 0.25MCG · CAPSULE · ORAL
CALCITRIOLPrescription
CALCITRIOL 0.5MCG · CAPSULE · ORAL

Approval history

2014-12-12OriginalAP
VIEW ON DRUGS@FDA ↗

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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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