APPLICATION
ANDA208964
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-22
LATEST ACTION
2023-10-23
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
TOBRAMYCINPrescription
TOBRAMYCIN 300MG/5ML · SOLUTION · INHALATION
Approval history
2023-10-23Labeling · Supplement 4 · standardAP
2020-02-06Labeling · Supplement 3 · standardAP
2017-03-22UNKNOWN · Original · 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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