APPLICATION
NDA018335
TYPE
NDA
ORIGINAL APPROVAL
1982-08-05
LATEST ACTION
1988-08-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMERSCAN MDP KITDiscontinued
TECHNETIUM TC-99M MEDRONATE KIT N/A · INJECTABLE · INJECTION
Approval history
1988-08-24Labeling · Supplement 2 · standardAP
1986-09-18Labeling · Supplement 1 · standardAP
1982-08-05Type 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.
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.