APPLICATION
ANDA061716
TYPE
ANDA
ORIGINAL APPROVAL
1981-03-03
LATEST ACTION
1999-01-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GARAMYCINDiscontinued
GENTAMICIN SULFATE EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
GARAMYCINDiscontinued
GENTAMICIN SULFATE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1999-01-04Manufacturing (CMC) · Supplement 7AP
1997-09-08Manufacturing (CMC) · Supplement 5AP
1996-11-29Manufacturing (CMC) · Supplement 4AP
1989-02-14Manufacturing (CMC) · Supplement 3AP
1981-03-03OriginalAP
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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