APPLICATION
ANDA063117
TYPE
ANDA
ORIGINAL APPROVAL
1991-04-26
LATEST ACTION
2023-01-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TOBRAMYCIN SULFATEPrescription
TOBRAMYCIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 9 · standardAP
2002-02-26Labeling · Supplement 8AP
2001-07-23Labeling · Supplement 7AP
2000-08-30Labeling · Supplement 6AP
2000-04-25Labeling · Supplement 5AP
1996-09-13Manufacturing (CMC) · Supplement 4AP
1994-08-17Manufacturing (CMC) · Supplement 2AP
1994-07-28Labeling · Supplement 3AP
1993-04-27Labeling · Supplement 1AP
1991-04-26OriginalAP
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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