APPLICATION
ANDA091589
TYPE
ANDA
ORIGINAL APPROVAL
2013-10-10
LATEST ACTION
2024-01-29
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
TOBRAMYCINPrescription
TOBRAMYCIN 300MG/5ML · SOLUTION · INHALATION
Approval history
2024-01-29Labeling · Supplement 12 · standardAP
2020-02-06Labeling · Supplement 10 · standardAP
2020-02-06Labeling · Supplement 9 · standardAP
2016-10-12Labeling · Supplement 5 · standardAP
2016-10-12Manufacturing (CMC) · Supplement 6AP
2015-09-01Labeling · Supplement 4 · 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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