APPLICATION
ANDA064096
TYPE
ANDA
ORIGINAL APPROVAL
1996-01-31
LATEST ACTION
2021-08-16
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
AKTOBDiscontinued
TOBRAMYCIN 0.3% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2021-08-16Labeling · Supplement 14 · standardAP
2012-07-11Labeling · Supplement 5AP
2001-06-05Manufacturing (CMC) · Supplement 3AP
1999-06-07Manufacturing (CMC) · Supplement 4AP
1997-03-19Manufacturing (CMC) · Supplement 1AP
1997-03-19Manufacturing (CMC) · Supplement 2AP
1996-01-31OriginalAP
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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