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FDA ANDA · ANDA207444

TOBRAMYCIN

Sponsor: SOMERSET THERAPS LLC

APPLICATION
ANDA207444
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-28
LATEST ACTION
2024-02-20
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

TOBRAMYCINPrescription
TOBRAMYCIN 0.3% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2024-02-20Labeling · Supplement 1 · standardAP
2024-02-20Labeling · Supplement 4 · standardAP
2024-02-20Labeling · Supplement 3 · standardAP
2017-06-28UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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