APPLICATION
NDA050541
TYPE
NDA
ORIGINAL APPROVAL
1980-12-12
LATEST ACTION
2021-05-14
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
TOBREX · ReferenceDiscontinued
TOBRAMYCIN 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
Approval history
2012-12-18Manufacturing (CMC) · Supplement 23 · standardAP
2002-12-04Manufacturing (CMC) · Supplement 19 · standardAP
2002-05-02Manufacturing (CMC) · Supplement 18 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 15 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 14 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 12 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 13 · standardAP
1998-12-18Manufacturing (CMC) · Supplement 11 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 10 · standardAP
1998-01-15Manufacturing (CMC) · Supplement 9 · standardAP
1996-06-25Manufacturing (CMC) · Supplement 7 · standardAP
1996-03-05Manufacturing (CMC) · Supplement 6 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 4 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 5 · standardAP
1995-06-13Manufacturing (CMC) · Supplement 1 · standardAP
1994-07-27Manufacturing (CMC) · Supplement 3 · standardAP
1994-06-13Labeling · Supplement 2 · standardAP
1980-12-12Type 3 - New Dosage Form · Original · standardAP
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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