FDA Approval Activities for this Drug…

KLARON (sulfacetamide sodium) Lotion, 10%, Dermik , NDA 19-931/S-008 Sulfacetamide Sodium Ophthalmic Solution USP, Akorn, ANDA 40-215 & 40-216 FLUOROMETHOLONE; SULFACETAMIDE SODIUM Suspension/Drops; Ophthalmic 0.1%;10% FML-S ALLERGAN 087748 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM Ointment; Ophthalmic 0.2%;10% BLEPHAMIDE S.O.P. ALLERGAN 088791 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM Ointment; Ophthalmic 0.5%;10% VASOCIDIN NOVARTIS 012813 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM Suspension; Ophthalmic 0.2%;10% BLEPHAMIDE ALLERGAN 073630 AT PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 0.23% PHOSPHATE;10% SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE Alcon 074449 AT PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 0.23% PHOSPHATE;10% SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE BAUSCH AND LOMB 018988 AT PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 0.23% PHOSPHATE;10% VASOCIDIN NOVARTIS 019931 SULFACETAMIDE SODIUM Lotion; Topical 10% KLARON DERMIK 080021 AT SULFACETAMIDE SODIUM Ointment; Ophthalmic 10% CETAMIDE Alcon 080029 AT SULFACETAMIDE SODIUM Ointment; Ophthalmic 10% SULFACETAMIDE SODIUM Altana 040215 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 10% SULFACETAMIDE SODIUM Akorn 040216 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 30% SULFACETAMIDE SODIUM Akorn 080020 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 15% ISOPTO CETAMIDE Alcon 089560 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 10% SULFACETAMIDE SODIUM Alcon UNIVERSAL 080028 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 10% BLEPH-10 ALLERGAN 080028 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 30% BLEPH-30 ALLERGAN 040066 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 10% SULFACETAMIDE SODIUM BAUSCH AND LOMB 080660 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 10% OCUSULF-10 MIZA USA 080025 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 10% SULF-10 NOVARTIS 089047 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 15% SULF-15 NOVARTIS 080024 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 15% SULFACEL-15 OPTOPICS 089068 AT SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 30% SULFACETAMIDE SODIUM STERIS 087864 AT TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) Cream; Vaginal 3.7%;2.86%;3.42% TRIPLE SULFA ALPHARMA 087285 AT TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) Cream; Vaginal 3.7%;2.86%;3.42% TRIPLE SULFA Clay Park 088607 AT TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) Cream; Vaginal 3.7%;2.86%;3.42% GYNE-SULF G AND W 087887 AT TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) Cream; Vaginal 3.7%;2.86%;3.42% TRYSUL SAVAGE | FML-S (fluorometholone and sulfacetamide sodium) ophthalmic suspension, Allergan, Manufacturing Change or Addition

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