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FDA NDA · NDA050091

CHLOROPTIC

Sponsor: ALLERGAN

APPLICATION
NDA050091
TYPE
NDA
ORIGINAL APPROVAL
1968-03-20
LATEST ACTION
2002-04-12
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

CHLOROPTICDiscontinued
CHLORAMPHENICOL 0.5% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2002-04-12Manufacturing (CMC) · Supplement 44AP
2001-12-04Manufacturing (CMC) · Supplement 43AP
2001-04-12Manufacturing (CMC) · Supplement 41AP
2001-01-30Manufacturing (CMC) · Supplement 40 — Label ↗AP
2000-10-03Labeling · Supplement 8AP
2000-10-02Manufacturing (CMC) · Supplement 39AP
1997-10-24Manufacturing (CMC) · Supplement 38AP
1997-09-09Manufacturing (CMC) · Supplement 37AP
1996-03-18Manufacturing (CMC) · Supplement 36AP
1995-08-03Manufacturing (CMC) · Supplement 9AP
1989-04-05Labeling · Supplement 7AP
1988-12-02Manufacturing (CMC) · Supplement 6AP
1985-10-25Manufacturing (CMC) · Supplement 4AP
1985-10-25Manufacturing (CMC) · Supplement 3AP
1983-10-28Manufacturing (CMC) · Supplement 2AP
1983-02-25Labeling · Supplement 1AP
1982-07-28Manufacturing (CMC) · Supplement 34AP
1980-11-26Manufacturing (CMC) · Supplement 33AP
1979-10-31Manufacturing (CMC) · Supplement 30AP
1979-08-27Manufacturing (CMC) · Supplement 29AP
1979-05-22Manufacturing (CMC) · Supplement 28AP
1977-02-18Labeling · Supplement 27AP
1977-02-15Manufacturing (CMC) · Supplement 26AP
1976-12-28Labeling · Supplement 25AP
1976-10-13Labeling · Supplement 24AP
1976-07-20Manufacturing (CMC) · Supplement 23AP
1976-07-02Labeling · Supplement 22AP
1976-02-03Manufacturing (CMC) · Supplement 21AP
1975-11-21Manufacturing (CMC) · Supplement 20AP
1975-06-26Labeling · Supplement 18AP
1974-11-26Labeling · Supplement 17AP
1974-11-14Manufacturing (CMC) · Supplement 16AP
1974-08-22Labeling · Supplement 15AP
1974-05-20Labeling · Supplement 14AP
1974-01-18Labeling · Supplement 13AP
1972-02-11Manufacturing (CMC) · Supplement 11AP
1971-11-22Labeling · Supplement 12AP
1969-03-10Manufacturing (CMC) · Supplement 5AP
1968-03-20OriginalAP
VIEW ON DRUGS@FDA ↗

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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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