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FDA NDA · NDA050592

TOBRAMYCIN AND DEXAMETHASONE

Sponsor: SANDOZ

APPLICATION
NDA050592
TYPE
NDA
ORIGINAL APPROVAL
1988-08-18
LATEST ACTION
2025-04-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

TOBRADEX · ReferencePrescription
DEXAMETHASONE 0.1%, TOBRAMYCIN 0.3% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2025-04-07Manufacturing (CMC) · Supplement 51 — Letter ↗AP
2021-05-14Labeling · Supplement 46 · standard — Letter ↗AP
2021-05-14Labeling · Supplement 44 · standard — Letter ↗AP
2020-04-24Labeling · Supplement 43 · standard — Letter ↗AP
2003-06-23Labeling · Supplement 32 · standard — Letter ↗AP
2002-12-11Manufacturing (CMC) · Supplement 31 · standardAP
2002-12-04Manufacturing (CMC) · Supplement 30 · standardAP
2002-08-16Manufacturing (CMC) · Supplement 29 · standardAP
2001-04-02Manufacturing (CMC) · Supplement 27 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 28 · standardAP
2000-06-20Manufacturing (CMC) · Supplement 25 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 26 · standardAP
2000-02-04Manufacturing (CMC) · Supplement 24 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 23 · standardAP
1999-04-28Labeling · Supplement 17 · standardAP
1999-04-07Manufacturing (CMC) · Supplement 22 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 20 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 21 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 19 · standardAP
1998-02-11Manufacturing (CMC) · Supplement 18 · standardAP
1997-09-09Manufacturing (CMC) · Supplement 16 · standardAP
1997-07-31Manufacturing (CMC) · Supplement 15 · standardAP
1996-09-27Labeling · Supplement 13 · standardAP
1996-09-27Labeling · Supplement 14 · standardAP
1996-09-27Manufacturing (CMC) · Supplement 12 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 11 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 10 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 9 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 8 · standardAP
1994-10-27Labeling · Supplement 7 · standardAP
1993-08-31Manufacturing (CMC) · Supplement 3 · standardAP
1991-12-31Manufacturing (CMC) · Supplement 5 · standardAP
1991-12-31Labeling · Supplement 6AP
1988-08-18Type 4 - New Combination · Original · standardAP
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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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