APPLICATION
ANDA062628
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-25
LATEST ACTION
1999-02-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
CHLORAMPHENICOLDiscontinued
CHLORAMPHENICOL 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
1999-02-19Manufacturing (CMC) · Supplement 16AP
1999-02-02Manufacturing (CMC) · Supplement 14AP
1996-04-16Manufacturing (CMC) · Supplement 12AP
1995-07-19Manufacturing (CMC) · Supplement 13AP
1995-05-19Manufacturing (CMC) · Supplement 11AP
1993-11-17Labeling · Supplement 10AP
1993-02-19Labeling · Supplement 9AP
1992-01-09Labeling · Supplement 8AP
1988-11-30Manufacturing (CMC) · Supplement 7AP
1988-11-16Manufacturing (CMC) · Supplement 6AP
1985-09-25OriginalAP
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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