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FDA NDA · NDA050555

TOBREX

tobramycin

Sponsor: NOVARTIS

APPLICATION
NDA050555
TYPE
NDA
ORIGINAL APPROVAL
1981-11-25
LATEST ACTION
2021-05-14
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

TOBREX · ReferencePrescription
TOBRAMYCIN 0.3% · OINTMENT · OPHTHALMIC

Approval history

2021-05-14Labeling · Supplement 38 · standard — Letter ↗AP
2020-04-24Labeling · Supplement 37 · standard — Letter ↗AP
2015-09-10Manufacturing (CMC) · Supplement 35 · standardAP
2004-07-15Labeling · Supplement 21 · standard — Label ↗AP
2004-07-15Manufacturing (CMC) · Supplement 22 · standard — Label ↗AP
2003-03-18Labeling · Supplement 19 · standard — Label ↗AP
2003-03-18Labeling · Supplement 17 · standard — Label ↗AP
2003-03-18Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
1999-09-28Manufacturing (CMC) · Supplement 16 · standardAP
1999-04-07Manufacturing (CMC) · Supplement 15 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 14 · standardAP
1998-05-29Manufacturing (CMC) · Supplement 13 · standardAP
1996-11-29Manufacturing (CMC) · Supplement 11 · standardAP
1994-05-18Labeling · Supplement 10 · standardAP
1992-09-17Manufacturing (CMC) · Supplement 8 · standardAP
1992-02-03Manufacturing (CMC) · Supplement 9 · standardAP
1981-11-25Type 3 - New Dosage Form · 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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