APPLICATION
NDA012968
TYPE
NDA
ORIGINAL APPROVAL
1962-03-15
LATEST ACTION
1991-05-06
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued
Products
ORAGRAFIN CALCIUMDiscontinued
IPODATE CALCIUM 3GM/PACKET · GRANULE · ORAL
Approval history
1991-05-06Manufacturing (CMC) · Supplement 12 · priorityAP
1979-09-13Labeling · Supplement 10 · priorityAP
1978-06-08Labeling · Supplement 8 · priorityAP
1976-09-09Manufacturing (CMC) · Supplement 7 · priorityAP
1975-12-24Labeling · Supplement 6 · priorityAP
1962-03-15Type 2 - New Active Ingredient · 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.
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.