APPLICATION
NDA017972
TYPE
NDA
ORIGINAL APPROVAL
1977-12-16
LATEST ACTION
2025-05-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
OSTEOLITEDiscontinued
TECHNETIUM TC-99M MEDRONATE KIT N/A · INJECTABLE · INJECTION
Approval history
2002-07-30Manufacturing (CMC) · Supplement 15 · standardAP
2000-03-10Manufacturing (CMC) · Supplement 14 · standardAP
1991-04-04Manufacturing (CMC) · Supplement 13 · standardAP
1989-05-02Manufacturing (CMC) · Supplement 12 · standardAP
1989-04-03Labeling · Supplement 11AP
1985-01-07Manufacturing (CMC) · Supplement 9 · standardAP
1984-06-19Labeling · Supplement 8AP
1980-05-08Labeling · Supplement 3AP
1979-05-07Labeling · Supplement 2AP
1979-04-30Manufacturing (CMC) · Supplement 5 · standardAP
1978-11-13Labeling · Supplement 1AP
1977-12-16Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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