APPLICATION
ANDA080660
TYPE
ANDA
ORIGINAL APPROVAL
1972-08-24
LATEST ACTION
1996-03-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
OCUSULF-10Discontinued
SULFACETAMIDE SODIUM 10% · SOLUTION/DROPS · OPHTHALMIC
OCUSULF-30Discontinued
SULFACETAMIDE SODIUM 30% · SOLUTION/DROPS · OPHTHALMIC
Approval history
1996-03-07Manufacturing (CMC) · Supplement 46AP
1996-03-07Labeling · Supplement 45AP
1996-02-13Manufacturing (CMC) · Supplement 47AP
1993-05-06Labeling · Supplement 44AP
1992-07-07Manufacturing (CMC) · Supplement 42AP
1992-07-07Labeling · Supplement 43AP
1990-04-04Labeling · Supplement 41AP
1985-08-20Manufacturing (CMC) · Supplement 37AP
1985-06-19Manufacturing (CMC) · Supplement 34AP
1985-06-19Manufacturing (CMC) · Supplement 30AP
1985-06-19Manufacturing (CMC) · Supplement 39AP
1984-12-13Manufacturing (CMC) · Supplement 35AP
1984-02-07Manufacturing (CMC) · Supplement 32AP
1982-07-15Manufacturing (CMC) · Supplement 29AP
1972-08-24OriginalAP
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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