APPLICATION
ANDA062447
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-26
LATEST ACTION
2013-05-21
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
ERYTHROMYCINDiscontinued
ERYTHROMYCIN 0.5% · OINTMENT · OPHTHALMIC
Approval history
2013-05-21Manufacturing (CMC) · Supplement 29AP
2000-02-23Manufacturing (CMC) · Supplement 20AP
2000-02-23Labeling · Supplement 21AP
1996-08-13Manufacturing (CMC) · Supplement 16AP
1996-05-29Manufacturing (CMC) · Supplement 19AP
1996-03-27Manufacturing (CMC) · Supplement 17AP
1996-03-07Manufacturing (CMC) · Supplement 18AP
1995-12-05Labeling · Supplement 13AP
1995-10-27Manufacturing (CMC) · Supplement 14AP
1995-10-27Manufacturing (CMC) · Supplement 15AP
1995-07-11Manufacturing (CMC) · Supplement 12AP
1995-07-11Manufacturing (CMC) · Supplement 11AP
1991-10-16Manufacturing (CMC) · Supplement 10AP
1989-03-17Manufacturing (CMC) · Supplement 9AP
1983-09-26OriginalAP
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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