← FDA DRUG APPROVALS
FDA NDA · NDA018107
KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE
technetium tc 99m medronate
Sponsor: CARDINAL HEALTH 414
APPLICATION
NDA018107
TYPE
NDA
ORIGINAL APPROVAL
1981-02-17
LATEST ACTION
2025-05-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TECHNETIUM TC-99M MEDRONATE KITPrescription
TECHNETIUM TC-99M MEDRONATE KIT N/A · INJECTABLE · INJECTION
Approval history
2015-09-10Manufacturing (CMC) · Supplement 14 · standardAP
2014-02-21Manufacturing (CMC) · Supplement 12 · standardAP
1999-11-23Manufacturing (CMC) · Supplement 9 · standardAP
1997-03-04Manufacturing (CMC) · Supplement 4 · standardAP
1994-03-21Manufacturing (CMC) · Supplement 8 · standardAP
1993-03-24Labeling · Supplement 3AP
1993-03-24Labeling · Supplement 6AP
1992-09-30Manufacturing (CMC) · Supplement 7 · standardAP
1985-09-30Manufacturing (CMC) · Supplement 5 · standardAP
1982-04-12Labeling · Supplement 2AP
1981-04-13Manufacturing (CMC) · Supplement 1 · standardAP
1981-02-17Type 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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