APPLICATION
NDA050425
TYPE
NDA
ORIGINAL APPROVAL
1970-11-25
LATEST ACTION
2001-07-24
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
GARAMYCINDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE · OINTMENT · OPHTHALMIC
Approval history
2001-07-24Manufacturing (CMC) · Supplement 9AP
2000-03-09Manufacturing (CMC) · Supplement 8AP
1999-12-20Manufacturing (CMC) · Supplement 7AP
1997-08-21Manufacturing (CMC) · Supplement 5AP
1997-07-29Labeling · Supplement 4AP
1997-06-23Manufacturing (CMC) · Supplement 3AP
1996-11-13Manufacturing (CMC) · Supplement 2AP
1992-03-17Labeling · Supplement 1AP
1970-11-25OriginalAP
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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