APPLICATION
NDA050505
TYPE
NDA
ORIGINAL APPROVAL
1979-10-01
LATEST ACTION
1989-02-14
ROUTE
INTRATHECAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GARAMYCIN · ReferenceDiscontinued
GENTAMICIN SULFATE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRATHECAL
Approval history
1989-02-14Manufacturing (CMC) · Supplement 7 · standardAP
1987-03-20Manufacturing (CMC) · Supplement 6 · standardAP
1986-03-17Manufacturing (CMC) · Supplement 5 · standardAP
1983-10-17Labeling · Supplement 4 · standardAP
1983-05-17Labeling · Supplement 3 · standardAP
1982-10-29Labeling · Supplement 1 · standardAP
1980-10-21Labeling · Supplement 10 · standardAP
1980-03-18Labeling · Supplement 9 · standardAP
1979-10-01Type 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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