APPLICATION
ANDA080021
TYPE
ANDA
ORIGINAL APPROVAL
1972-09-27
LATEST ACTION
2000-01-18
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
CETAMIDEDiscontinued
SULFACETAMIDE SODIUM 10% · OINTMENT · OPHTHALMIC
Approval history
2000-01-18Manufacturing (CMC) · Supplement 17AP
1999-03-23Manufacturing (CMC) · Supplement 16AP
1996-12-12Manufacturing (CMC) · Supplement 15AP
1996-04-18Manufacturing (CMC) · Supplement 13AP
1996-04-18Manufacturing (CMC) · Supplement 14AP
1994-08-23Manufacturing (CMC) · Supplement 12AP
1993-08-31Labeling · Supplement 9AP
1993-08-31Labeling · Supplement 11AP
1992-08-19Manufacturing (CMC) · Supplement 10AP
1991-07-05Labeling · Supplement 8AP
1990-03-09Manufacturing (CMC) · Supplement 7AP
1990-03-09Manufacturing (CMC) · Supplement 5AP
1989-09-15Labeling · Supplement 6AP
1982-03-30Manufacturing (CMC) · Supplement 1AP
1972-09-27OriginalAP
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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