APPLICATION
NDA050143
TYPE
NDA
ORIGINAL APPROVAL
1951-06-01
LATEST ACTION
1996-08-14
ROUTE
OPHTHALMIC
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
CHLOROMYCETINDiscontinued
CHLORAMPHENICOL 25MG/VIAL · FOR SOLUTION · OPHTHALMIC
Approval history
1996-08-14Labeling · Supplement 16AP
1988-12-01Manufacturing (CMC) · Supplement 5AP
1986-09-29Manufacturing (CMC) · Supplement 4AP
1983-11-08Labeling · Supplement 1AP
1983-09-23Manufacturing (CMC) · Supplement 2AP
1982-09-28Manufacturing (CMC) · Supplement 15AP
1981-04-08Manufacturing (CMC) · Supplement 14AP
1981-01-08Labeling · Supplement 13AP
1979-11-08Labeling · Supplement 12AP
1978-08-03Manufacturing (CMC) · Supplement 11AP
1978-06-29Labeling · Supplement 10AP
1977-02-23Manufacturing (CMC) · Supplement 9AP
1958-02-24Manufacturing (CMC) · Supplement 8AP
1956-08-30Manufacturing (CMC) · Supplement 6AP
1951-06-01OriginalAP
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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