APPLICATION
ANDA062247
TYPE
ANDA
ORIGINAL APPROVAL
1980-04-28
LATEST ACTION
1997-05-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CHLORAMPHENICOLDiscontinued
CHLORAMPHENICOL 250MG · CAPSULE · ORAL
Approval history
1997-05-30Manufacturing (CMC) · Supplement 11AP
1992-11-16Manufacturing (CMC) · Supplement 9AP
1992-09-02Labeling · Supplement 10AP
1992-08-14Manufacturing (CMC) · Supplement 8AP
1980-04-28OriginalAP
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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