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FDA NDA · NDA050753

TOBI

tobramycin

Sponsor: VIATRIS

APPLICATION
NDA050753
TYPE
NDA
ORIGINAL APPROVAL
1997-12-22
LATEST ACTION
2023-02-10
ROUTE
ORAL, RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TOBI · ReferencePrescription
TOBRAMYCIN 300MG/5ML · SOLUTION · INHALATION

Approval history

2023-02-10Labeling · Supplement 28 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 23 · standard — Letter ↗AP
2018-10-05Labeling · Supplement 22 · standard — Letter ↗AP
2016-04-29Manufacturing (CMC) · Supplement 19 · priorityAP
2015-10-05Labeling · Supplement 18 · standard — Letter ↗AP
2015-04-14Manufacturing (CMC) · Supplement 17 · priorityAP
2014-04-25Labeling · Supplement 16 · standard — Label ↗AP
2013-10-24Manufacturing (CMC) · Supplement 15 · priorityAP
2013-09-26Labeling · Supplement 11 · standard — Label ↗AP
2008-10-16Labeling · Supplement 9 · standard — Letter ↗AP
2005-08-05Labeling · Supplement 7 · standardAP
2002-03-21Labeling · Supplement 2 · standard — Letter ↗AP
2001-09-05Manufacturing (CMC) · Supplement 4 · priorityAP
2000-05-18Manufacturing (CMC) · Supplement 3 · priorityAP
1998-09-11Labeling · Supplement 1 · standardAP
1997-12-22Type 3 - New Dosage Form · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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