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FDA NDA · NDA205433

TOBRAMYCIN INHALATION SOLUTION PAK

tobramycin

Sponsor: PULMOFLOW INC

APPLICATION
NDA205433
TYPE
NDA
ORIGINAL APPROVAL
2014-12-02
LATEST ACTION
2023-04-10
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

KITABIS PAKPrescription
TOBRAMYCIN 300MG/5ML · SOLUTION · INHALATION

Approval history

2023-04-10Labeling · Supplement 8 · standard — Letter ↗AP
2023-02-10Labeling · Supplement 7 · standard — Letter ↗AP
2019-12-06Labeling · Supplement 5 · standard — Label ↗AP
2016-11-18Manufacturing (CMC) · Supplement 1 · standardAP
2014-12-02Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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