APPLICATION
NDA050155
TYPE
NDA
ORIGINAL APPROVAL
1959-02-20
LATEST ACTION
2005-08-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CHLOROMYCETIN · ReferenceDiscontinued
CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
1999-12-14Labeling · Supplement 37AP
1999-08-11Manufacturing (CMC) · Supplement 38AP
1999-03-08Manufacturing (CMC) · Supplement 36AP
1994-08-24Manufacturing (CMC) · Supplement 35AP
1994-06-16Manufacturing (CMC) · Supplement 34AP
1988-04-21Manufacturing (CMC) · Supplement 6AP
1988-01-22Manufacturing (CMC) · Supplement 5AP
1987-06-10Manufacturing (CMC) · Supplement 3AP
1986-03-28Manufacturing (CMC) · Supplement 2AP
1984-01-31Manufacturing (CMC) · Supplement 1AP
1981-05-26Manufacturing (CMC) · Supplement 33AP
1980-03-26Manufacturing (CMC) · Supplement 32AP
1979-12-10Labeling · Supplement 31AP
1978-12-07Manufacturing (CMC) · Supplement 30AP
1978-08-03Manufacturing (CMC) · Supplement 29AP
1978-04-04Manufacturing (CMC) · Supplement 28AP
1977-11-10Manufacturing (CMC) · Supplement 26AP
1977-10-17Manufacturing (CMC) · Supplement 25AP
1977-07-16Manufacturing (CMC) · Supplement 24AP
1977-02-23Manufacturing (CMC) · Supplement 23AP
1975-07-22Manufacturing (CMC) · Supplement 18AP
1974-06-11Manufacturing (CMC) · Supplement 19AP
1973-10-09Manufacturing (CMC) · Supplement 17AP
1966-07-28Manufacturing (CMC) · Supplement 16AP
1962-06-25Manufacturing (CMC) · Supplement 12AP
1962-06-25Manufacturing (CMC) · Supplement 13AP
1961-05-05Manufacturing (CMC) · Supplement 10AP
1961-05-05Manufacturing (CMC) · Supplement 9AP
1961-03-22Labeling · Supplement 8AP
1959-02-20OriginalAP
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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