APPLICATION
NDA050039
TYPE
NDA
ORIGINAL APPROVAL
1970-06-19
LATEST ACTION
1999-10-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
GARAMYCIN · ReferenceDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
Approval history
1999-10-18Manufacturing (CMC) · Supplement 21AP
1999-09-20Manufacturing (CMC) · Supplement 20AP
1999-07-28Manufacturing (CMC) · Supplement 19AP
1997-08-21Manufacturing (CMC) · Supplement 17AP
1997-07-29Labeling · Supplement 16AP
1996-11-13Manufacturing (CMC) · Supplement 15AP
1992-03-17Labeling · Supplement 6AP
1989-02-14Manufacturing (CMC) · Supplement 5AP
1987-03-20Manufacturing (CMC) · Supplement 4AP
1986-05-15Manufacturing (CMC) · Supplement 1AP
1986-03-12Manufacturing (CMC) · Supplement 3AP
1985-10-25Manufacturing (CMC) · Supplement 2AP
1981-07-13Manufacturing (CMC) · Supplement 14AP
1981-02-24Manufacturing (CMC) · Supplement 13AP
1980-06-24Labeling · Supplement 12AP
1979-09-18Labeling · Supplement 11AP
1979-01-25Manufacturing (CMC) · Supplement 10AP
1974-03-27Manufacturing (CMC) · Supplement 8AP
1972-04-11Manufacturing (CMC) · Supplement 7AP
1970-06-19OriginalAP
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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