APPLICATION
ANDA062533
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-05
LATEST ACTION
2004-10-29
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
GENTAMICIN SULFATEPrescription
GENTAMICIN SULFATE EQ 0.1% BASE · OINTMENT · TOPICAL
Approval history
2004-10-29Labeling · Supplement 6AP
2002-03-19Manufacturing (CMC) · Supplement 5AP
1996-03-07Manufacturing (CMC) · Supplement 4AP
1996-02-02Manufacturing (CMC) · Supplement 3AP
1989-04-26Manufacturing (CMC) · Supplement 2AP
1984-10-05OriginalAP
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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