APPLICATION
ANDA064067
TYPE
ANDA
ORIGINAL APPROVAL
1994-07-29
LATEST ACTION
2002-08-20
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
ERYTHROMYCINPrescription
ERYTHROMYCIN 0.5% · OINTMENT · OPHTHALMIC
Approval history
2002-08-20Manufacturing (CMC) · Supplement 16AP
2002-02-05Manufacturing (CMC) · Supplement 15AP
2001-11-27Manufacturing (CMC) · Supplement 14AP
2001-03-07Manufacturing (CMC) · Supplement 13AP
2000-06-27Manufacturing (CMC) · Supplement 12AP
2000-05-01Manufacturing (CMC) · Supplement 11AP
1999-06-07Manufacturing (CMC) · Supplement 9AP
1999-03-31Manufacturing (CMC) · Supplement 7AP
1999-03-31Manufacturing (CMC) · Supplement 8AP
1998-10-22Manufacturing (CMC) · Supplement 5AP
1998-05-04Manufacturing (CMC) · Supplement 6AP
1997-05-21Labeling · Supplement 4AP
1996-09-24Labeling · Supplement 2AP
1996-01-31Manufacturing (CMC) · Supplement 3AP
1995-02-01Manufacturing (CMC) · Supplement 1AP
1994-07-29OriginalAP
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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