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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUMEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074449-001SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEEQ 0.23% PHOSPHATE;10%SOLUTION/DROPS / OPHTHALMICRS1995-12-29a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfacetamide Sodium and Prednisolone Sodium PhosphateSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATENuCare Pharmaceuticals,Inc.835def0b-ed5a-61a0-e053-2a91aa0ae7ae2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074449
application number: ANDA074449
ndc (product): 68071-1650
Sulfacetamide Sodium and Prednisolone Sodium PhosphateSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEBausch & Lomb Incoporated9ec403eb-b5df-4e41-9e17-9d9d8ecac3f32023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074449
application number: ANDA074449
ndc (product): 24208-317

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

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