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FDA ANDA · ANDA063081
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
ANDA063081
TYPE
ANDA
ORIGINAL APPROVAL
1990-07-31
LATEST ACTION
2023-02-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
TOBRAMYCIN SULFATE EQ 1.6MG BASE/ML · INJECTABLE · INJECTION
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
TOBRAMYCIN SULFATE EQ 1.2MG BASE/ML · INJECTABLE · INJECTION
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
TOBRAMYCIN SULFATE EQ 80MG BASE/100ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 37 · standardAP
2015-09-18Labeling · Supplement 35 · standardAP
2004-10-21Labeling · Supplement 18AP
2002-11-01Manufacturing (CMC) · Supplement 17AP
1999-02-16Manufacturing (CMC) · Supplement 16AP
1998-12-01Manufacturing (CMC) · Supplement 15AP
1997-06-02Manufacturing (CMC) · Supplement 13AP
1997-05-02Manufacturing (CMC) · Supplement 14AP
1996-07-03Manufacturing (CMC) · Supplement 10AP
1996-03-12Manufacturing (CMC) · Supplement 11AP
1994-05-05Labeling · Supplement 8AP
1994-03-11Labeling · Supplement 9AP
1994-01-14Manufacturing (CMC) · Supplement 7AP
1993-06-02Labeling · Supplement 6AP
1993-06-02Manufacturing (CMC) · Supplement 5AP
1992-03-10Manufacturing (CMC) · Supplement 3AP
1992-03-10Manufacturing (CMC) · Supplement 4AP
1991-01-18Manufacturing (CMC) · Supplement 1AP
1990-07-31OriginalAP
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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