APPLICATION
NDA019545
TYPE
NDA
ORIGINAL APPROVAL
1987-04-20
LATEST ACTION
2002-06-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DIDRONELDiscontinued
ETIDRONATE DISODIUM 50MG/ML · INJECTABLE · INJECTION
Approval history
2002-06-26Manufacturing (CMC) · Supplement 6 · standardAP
1998-09-22Labeling · Supplement 5 · standardAP
1998-04-01Labeling · Supplement 4 · standardAP
1993-09-28Labeling · Supplement 3 · standardAP
1992-07-21Manufacturing (CMC) · Supplement 2 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 1 · standardAP
1987-04-20Type 3 - New Dosage Form · 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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