← FDA DRUG APPROVALS

FDA NDA · NDA201820

TOBRAMYCIN INHALATION

Sponsor: CHIESI

APPLICATION
NDA201820
TYPE
NDA
ORIGINAL APPROVAL
2012-10-12
LATEST ACTION
2023-02-10
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BETHKIS · ReferencePrescription
TOBRAMYCIN 300MG/4ML · SOLUTION · INHALATION

Approval history

2023-02-10Labeling · Supplement 6 · standard — Letter ↗AP
2019-12-09Labeling · Supplement 5 · standard — Label ↗AP
2017-05-29Labeling · Supplement 3 · standard — Letter ↗AP
2015-02-16Manufacturing (CMC) · Supplement 1 · standardAP
2012-10-12Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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