APPLICATION
NDA050156
TYPE
NDA
ORIGINAL APPROVAL
1951-06-01
LATEST ACTION
1999-02-03
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
CHLOROMYCETINDiscontinued
CHLORAMPHENICOL 1% · OINTMENT · OPHTHALMIC
Approval history
1999-02-03Labeling · Supplement 38AP
1999-02-03Manufacturing (CMC) · Supplement 39AP
1998-02-25Manufacturing (CMC) · Supplement 40AP
1996-08-27Labeling · Supplement 34AP
1986-08-27Manufacturing (CMC) · Supplement 36AP
1983-11-08Labeling · Supplement 35AP
1983-07-22Manufacturing (CMC) · Supplement 2AP
1983-04-19Manufacturing (CMC) · Supplement 33AP
1983-04-19Manufacturing (CMC) · Supplement 1AP
1982-03-24Manufacturing (CMC) · Supplement 32AP
1981-01-08Labeling · Supplement 31AP
1979-12-30Manufacturing (CMC) · Supplement 30AP
1977-05-19Manufacturing (CMC) · Supplement 29AP
1977-02-23Manufacturing (CMC) · Supplement 28AP
1973-07-11Labeling · Supplement 27AP
1973-03-23Labeling · Supplement 26AP
1973-03-23Labeling · Supplement 24AP
1972-09-12Labeling · Supplement 21AP
1972-08-09Labeling · Supplement 25AP
1972-06-27Manufacturing (CMC) · Supplement 23AP
1972-03-22Manufacturing (CMC) · Supplement 22AP
1971-07-12Labeling · Supplement 20AP
1971-05-03Labeling · Supplement 19AP
1969-10-28Manufacturing (CMC) · Supplement 18AP
1964-11-05Manufacturing (CMC) · Supplement 17AP
1963-12-10Labeling · Supplement 15AP
1963-12-10Labeling · Supplement 16AP
1963-08-26Labeling · Supplement 14AP
1963-06-11Labeling · Supplement 13AP
1963-04-08Labeling · Supplement 12AP
1962-07-26Labeling · Supplement 11AP
1961-12-01Labeling · Supplement 9AP
1961-12-01Labeling · Supplement 10AP
1961-05-19Labeling · Supplement 8AP
1961-05-19Labeling · Supplement 7AP
1957-04-17Manufacturing (CMC) · Supplement 6AP
1955-08-17Manufacturing (CMC) · Supplement 5AP
1953-04-30Manufacturing (CMC) · Supplement 4AP
1952-09-09Manufacturing (CMC) · Supplement 3AP
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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