FDA.reportPublic FDA data

Application 074449

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUMSOLUTION/DROPS;OPHTHALMICEQ 0.23% PHOSPHATE;10%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-186Sulfacetamide Sodium and Prednisolone Sodium Phosphatesulfacetamide sodium and prednisolone sodium phosphateRebel Distributors CorpANDACurrent
24208-317Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateBausch & Lomb IncoporatedANDACurrent
24208-317Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateBausch & Lomb IncoporatedANDACurrent
24208-317Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateBausch & Lomb IncoporatedANDACurrent
24208-317Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateBausch & Lomb IncoporatedANDACurrent
53002-8690Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateRPK Pharmaceuticals, Inc.ANDACurrent
53002-8690Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateRPK Pharmaceuticals, Inc.ANDACurrent
68071-1650Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1650Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2559Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-2559Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-2559Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-2559Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-2559Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-2559Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-2559Sulfacetamide Sodium and Prednisolone Sodium PhosphateSulfacetamide Sodium and Prednisolone Sodium PhosphateREMEDYREPACK INC.ANDACurrent