APPLICATION
ANDA205501
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-13
LATEST ACTION
2023-07-10
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
TOBRAMYCINPrescription
TOBRAMYCIN 300MG/5ML · SOLUTION · INHALATION
Approval history
2023-07-10Labeling · Supplement 13 · standardAP
2020-02-21Labeling · Supplement 5 · standardAP
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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