APPLICATION
ANDA201422
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-28
LATEST ACTION
2024-09-30
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
TOBRAMYCINPrescription
TOBRAMYCIN 300MG/5ML · SOLUTION · INHALATION
Approval history
2024-09-30Labeling · Supplement 9 · standardAP
2020-01-21Labeling · Supplement 4 · standardAP
2020-01-21Labeling · Supplement 3 · standardAP
2020-01-21Labeling · Supplement 1 · standardAP
2014-05-28Not Applicable · OriginalAP
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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