APPLICATION
ANDA075765
TYPE
ANDA
ORIGINAL APPROVAL
2001-10-12
LATEST ACTION
2008-07-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CALCITRIOLPrescription
CALCITRIOL 0.5MCG · CAPSULE · ORAL
CALCITRIOLPrescription
CALCITRIOL 0.25MCG · CAPSULE · ORAL
Approval history
2008-07-24Labeling · Supplement 4AP
2007-02-21Labeling · Supplement 3AP
2002-09-18Labeling · Supplement 2AP
2002-04-16Manufacturing (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.
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