APPLICATION
ANDA064048
TYPE
ANDA
ORIGINAL APPROVAL
1994-05-11
LATEST ACTION
2001-11-27
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
GENTAMICIN SULFATEPrescription
GENTAMICIN SULFATE EQ 0.3% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2001-11-27Manufacturing (CMC) · Supplement 14AP
2001-08-29Manufacturing (CMC) · Supplement 13AP
2001-03-07Manufacturing (CMC) · Supplement 12AP
2000-10-05Manufacturing (CMC) · Supplement 11AP
2000-06-27Manufacturing (CMC) · Supplement 10AP
2000-05-18Manufacturing (CMC) · Supplement 7AP
2000-05-15Manufacturing (CMC) · Supplement 9AP
2000-04-28Manufacturing (CMC) · Supplement 8AP
1999-06-07Manufacturing (CMC) · Supplement 6AP
1998-11-19Manufacturing (CMC) · Supplement 5AP
1998-05-04Manufacturing (CMC) · Supplement 4AP
1998-01-14Manufacturing (CMC) · Supplement 3AP
1996-08-26Manufacturing (CMC) · Supplement 2AP
1994-09-09Manufacturing (CMC) · Supplement 1AP
1994-05-11OriginalAP
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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