APPLICATION
ANDA062196
TYPE
ANDA
ORIGINAL APPROVAL
1980-07-02
LATEST ACTION
2002-12-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
GENTAMICIN SULFATEPrescription
GENTAMICIN SULFATE EQ 0.3% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-12-23Manufacturing (CMC) · Supplement 15AP
2000-11-17Manufacturing (CMC) · Supplement 14AP
2000-09-12Manufacturing (CMC) · Supplement 13AP
2000-04-28Manufacturing (CMC) · Supplement 11AP
2000-04-07Manufacturing (CMC) · Supplement 12AP
1999-05-07Manufacturing (CMC) · Supplement 10AP
1998-09-18Labeling · Supplement 5AP
1998-04-03Manufacturing (CMC) · Supplement 8AP
1997-07-29Manufacturing (CMC) · Supplement 7AP
1997-07-29Manufacturing (CMC) · Supplement 6AP
1997-06-09Manufacturing (CMC) · Supplement 4AP
1996-12-09Manufacturing (CMC) · Supplement 3AP
1996-07-12Manufacturing (CMC) · Supplement 2AP
1995-12-28Manufacturing (CMC) · Supplement 1AP
1980-07-02OriginalAP
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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