APPLICATION
ANDA063116
TYPE
ANDA
ORIGINAL APPROVAL
1992-05-18
LATEST ACTION
2011-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TOBRAMYCIN SULFATE (PHARMACY BULK)Discontinued
TOBRAMYCIN SULFATE EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2004-10-04Labeling · Supplement 7AP
2002-10-25Manufacturing (CMC) · Supplement 6AP
1999-02-16Manufacturing (CMC) · Supplement 5AP
1996-10-03Manufacturing (CMC) · Supplement 3AP
1994-08-02Labeling · Supplement 1AP
1992-05-18OriginalAP
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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