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FDA NDA · NDA050789

TOBRAMYCIN

tobramycin sulfate

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA050789
TYPE
NDA
ORIGINAL APPROVAL
2004-07-13
LATEST ACTION
2023-02-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TOBRAMYCIN SULFATEPrescription
TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2023-02-10Labeling · Supplement 17 · standard — Letter ↗AP
2021-04-15Labeling · Supplement 12 · standard — Letter ↗AP
2020-04-03Labeling · Supplement 6 · standard — Label ↗AP
2013-02-16Manufacturing (CMC) · Supplement 8 · standardAP
2009-08-10Labeling · Supplement 27 · standard — Letter ↗AP
2009-08-10Labeling · Supplement 5 · standard — Label ↗AP
2004-07-13Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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