APPLICATION
NDA050404
TYPE
NDA
ORIGINAL APPROVAL
1950-01-23
LATEST ACTION
1988-12-01
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
AUREOMYCINDiscontinued
CHLORTETRACYCLINE HYDROCHLORIDE 1% · OINTMENT · OPHTHALMIC
Approval history
1988-12-01Manufacturing (CMC) · Supplement 4AP
1986-05-23Manufacturing (CMC) · Supplement 3AP
1983-10-26Manufacturing (CMC) · Supplement 1AP
1975-05-13Manufacturing (CMC) · Supplement 19AP
1974-05-08Manufacturing (CMC) · Supplement 17AP
1974-05-07Manufacturing (CMC) · Supplement 18AP
1973-12-20Manufacturing (CMC) · Supplement 16AP
1973-10-10Manufacturing (CMC) · Supplement 15AP
1969-01-15Manufacturing (CMC) · Supplement 14AP
1963-05-01Labeling · Supplement 13AP
1961-04-06Manufacturing (CMC) · Supplement 12AP
1959-09-18Manufacturing (CMC) · Supplement 11AP
1959-04-09Manufacturing (CMC) · Supplement 10AP
1958-04-01Labeling · Supplement 9AP
1952-03-11Manufacturing (CMC) · Supplement 8AP
1951-01-02Manufacturing (CMC) · Supplement 7AP
1950-04-07Labeling · Supplement 6AP
1950-03-31Labeling · Supplement 2AP
1950-01-23UNKNOWN · Original · unknownAP
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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