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

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

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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