APPLICATION
ANDA062535
TYPE
ANDA
ORIGINAL APPROVAL
1984-12-13
LATEST ACTION
2021-06-24
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
TOBREXPrescription
TOBRAMYCIN 0.3% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2021-06-24Labeling · Supplement 33 · standardAP
2021-06-24Labeling · Supplement 31 · standardAP
2020-05-18Labeling · Supplement 30 · standardAP
2005-08-22Labeling · Supplement 23AP
2004-10-13Labeling · Supplement 22AP
2002-12-23Manufacturing (CMC) · Supplement 21AP
2002-10-03Manufacturing (CMC) · Supplement 19AP
2002-10-03Manufacturing (CMC) · Supplement 20AP
2000-04-28Manufacturing (CMC) · Supplement 17AP
1999-05-07Manufacturing (CMC) · Supplement 14AP
1999-04-21Manufacturing (CMC) · Supplement 16AP
1999-03-23Manufacturing (CMC) · Supplement 15AP
1999-03-04Manufacturing (CMC) · Supplement 12AP
1998-12-31Manufacturing (CMC) · Supplement 13AP
1997-03-19Manufacturing (CMC) · Supplement 11AP
1996-04-01Manufacturing (CMC) · Supplement 9AP
1995-12-06Manufacturing (CMC) · Supplement 6AP
1995-12-06Manufacturing (CMC) · Supplement 5AP
1995-10-05Manufacturing (CMC) · Supplement 8AP
1995-08-04Manufacturing (CMC) · Supplement 7AP
1994-07-14Labeling · Supplement 4AP
1990-12-04Manufacturing (CMC) · Supplement 3AP
1984-12-13OriginalAP
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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