APPLICATION
NDA018044
TYPE
NDA
ORIGINAL APPROVAL
1978-08-17
LATEST ACTION
2010-02-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ROCALTROL · ReferencePrescription
CALCITRIOL 0.5MCG · CAPSULE · ORAL
ROCALTROL · ReferencePrescription
CALCITRIOL 0.25MCG · CAPSULE · ORAL
Approval history
2001-11-12Manufacturing (CMC) · Supplement 30 · priorityAP
2001-10-15Manufacturing (CMC) · Supplement 29 · priorityAP
2000-12-15Manufacturing (CMC) · Supplement 27 · priorityAP
1999-04-27Manufacturing (CMC) · Supplement 26 · priorityAP
1995-12-15Manufacturing (CMC) · Supplement 22 · priorityAP
1995-05-26Manufacturing (CMC) · Supplement 23 · priorityAP
1993-09-24Manufacturing (CMC) · Supplement 21 · priorityAP
1991-09-24Manufacturing (CMC) · Supplement 20 · priorityAP
1988-04-27Labeling · Supplement 17AP
1988-04-27Manufacturing (CMC) · Supplement 16 · priorityAP
1986-09-16Manufacturing (CMC) · Supplement 10 · priorityAP
1986-05-16Labeling · Supplement 15AP
1986-01-22Efficacy · Supplement 12AP
1985-12-20Manufacturing (CMC) · Supplement 14 · priorityAP
1984-08-20Manufacturing (CMC) · Supplement 11 · priorityAP
1983-11-04Labeling · Supplement 9AP
1982-04-22Labeling · Supplement 8AP
1982-04-22Efficacy · Supplement 4AP
1980-12-10Manufacturing (CMC) · Supplement 6 · priorityAP
1980-05-12Manufacturing (CMC) · Supplement 5 · priorityAP
1979-11-09Manufacturing (CMC) · Supplement 2 · priorityAP
1978-12-06Manufacturing (CMC) · Supplement 1 · priorityAP
1978-08-17Type 1 - New Molecular Entity · Original · priorityAP
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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