FDA.reportPublic FDA data

Application 083021

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM SULFACETAMIDESULFACETAMIDE SODIUMSOLUTION/DROPS;OPHTHALMIC10%NoNo
002SODIUM SULFACETAMIDESULFACETAMIDE SODIUMSOLUTION/DROPS;OPHTHALMIC15%NoNo
003SODIUM SULFACETAMIDESULFACETAMIDE SODIUMSOLUTION/DROPS;OPHTHALMIC30%NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083021-001SODIUM SULFACETAMIDESULFACETAMIDE SODIUM10%SOLUTION/DROPS / OPHTHALMICApproved before 1982
A083021-002SODIUM SULFACETAMIDESULFACETAMIDE SODIUM15%SOLUTION/DROPS / OPHTHALMICApproved before 1982
A083021-003SODIUM SULFACETAMIDESULFACETAMIDE SODIUM30%SOLUTION/DROPS / OPHTHALMICApproved before 1982

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A083021-001SODIUM SULFACETAMIDE10%SOLUTION/DROPS / OPHTHALMICApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A083021-002SODIUM SULFACETAMIDE15%SOLUTION/DROPS / OPHTHALMICApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A083021-003SODIUM SULFACETAMIDE30%SOLUTION/DROPS / OPHTHALMICApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A083021-001SODIUM SULFACETAMIDE10%SOLUTION/DROPS / OPHTHALMICApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A083021-002SODIUM SULFACETAMIDE15%SOLUTION/DROPS / OPHTHALMICApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A083021-003SODIUM SULFACETAMIDE30%SOLUTION/DROPS / OPHTHALMICApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A083021-001SODIUM SULFACETAMIDE10%SOLUTION/DROPS / OPHTHALMICApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A083021-002SODIUM SULFACETAMIDE15%SOLUTION/DROPS / OPHTHALMICApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A083021-003SODIUM SULFACETAMIDE30%SOLUTION/DROPS / OPHTHALMICApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A083021-001SODIUM SULFACETAMIDE10%SOLUTION/DROPS / OPHTHALMICApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A083021-002SODIUM SULFACETAMIDE15%SOLUTION/DROPS / OPHTHALMICApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A083021-003SODIUM SULFACETAMIDE30%SOLUTION/DROPS / OPHTHALMICApproved before 1982a50c72e98297…

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfacetamide SodiumSULFACETAMIDE SODIUMPreferred Pharmaceuticals, Inccf0cc763-49b5-435d-852b-e7617c8d32862026-09-02Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
SODIUM SULFACETAMIDESODIUM SULFACETAMIDEAcella Pharmaceuticals, LLC77671f48-b574-490f-a1c2-b321af8dac522026-07-13Warnings, Adverse reactionsName fallback
brand name: SODIUM SULFACETAMIDE
Sodium SulfacetamideSODIUM SULFACETAMIDEBryant Ranch Prepack3cc796f7-b1e9-4804-9009-2bf578ba7a532026-04-24WarningsName fallback
brand name: Sodium Sulfacetamide
Sodium SulfacetamideSODIUM SULFACETAMIDEBryant Ranch Prepackc9f90612-32c6-44ba-85d5-82842f0e1ba92026-04-24WarningsName fallback
brand name: Sodium Sulfacetamide
Sodium SulfacetamideSODIUM SULFACETAMIDEBryant Ranch Prepacked2ab442-617b-472a-a7a3-f178b5b8c4412026-04-24WarningsName fallback
brand name: Sodium Sulfacetamide
Sulfacetamide SodiumSULFACETAMIDE SODIUMA-S Medication Solutionsf212af23-be3d-4e82-9f6f-5ddce12a89da2026-03-23Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sodium SulfacetamideSODIUM SULFACETAMIDEMethod Pharmaceuticals, LLCd65e777b-682b-732d-e053-2a95a90a41ad2026-02-12WarningsName fallback
brand name: Sodium Sulfacetamide
SODIUM SULFACETAMIDESODIUM SULFACETAMIDEBioComp Pharma, Inc.efde52a6-216d-4ccc-8574-5e3e41ec7e062026-01-12Warnings, Adverse reactionsName fallback
brand name: SODIUM SULFACETAMIDE
OVACESULFACETAMIDE SODIUMMission Pharmacal Companya77aed6c-355f-44ed-ae95-78b4d1549c2b2026-01-08Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
SODIUM SULFACETAMIDESODIUM SULFACETAMIDEBioComp Pharma, Inc.d8954bfa-2acf-445a-9810-62cfd5d469b32025-12-17Warnings, Adverse reactionsName fallback
brand name: SODIUM SULFACETAMIDE
Sodium Sulfacetamide, SulfurSULFACETAMIDE SODIUMBioComp Pharma, Inc.ed616ece-09b5-41d5-ae58-8e016da2c6b32025-12-17Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMBioComp Pharma, Inc.f79c8287-a832-4f39-ad4d-3a12d64618ab2025-12-17Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sodium SulfacetamideSODIUM SULFACETAMIDEBioComp Pharma, Inc.ac7863c6-387c-4c90-bfaa-5f1544e1e8872025-12-17Warnings, Adverse reactionsName fallback
brand name: Sodium Sulfacetamide
OVACE PlusSULFACETAMIDE SODIUMMission Pharmacal Companyeca5fc5d-35d0-4803-990d-1f38f860c52a2025-12-03Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
OVACE PlusSULFACETAMIDE SODIUMMission Pharmacal Company6a034465-e600-49cb-91bd-7b9ceee6ffc62025-12-03Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Ovace PlusSULFACETAMIDE SODIUMMission Pharmacal Company073a44cd-f679-48bd-b90d-cf06f32ff07d2025-08-13Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
OvacePlus PlusSULFACETAMIDE SODIUMMission Pharmacal Company06876575-edf2-4844-8f20-3eb6e74ccc8e2025-08-12Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sodium SulfacetamideSODIUM SULFACETAMIDELaser Pharmaceuticals, LLC055a586a-a840-0205-e063-6394a90a44cb2025-07-03Warnings, Adverse reactionsName fallback
brand name: Sodium Sulfacetamide
Sodium SulfacetamideSODIUM SULFACETAMIDELaser Pharmaceuticals, LLCbdc2211e-6d20-1500-e053-2a95a90ab1452025-04-23Warnings, Adverse reactionsName fallback
brand name: Sodium Sulfacetamide
Sodium SulfacetamideSODIUM SULFACETAMIDEBryant Ranch Prepackacd3fb4a-558d-4565-84d8-23a0d917eab62024-12-24WarningsName fallback
brand name: Sodium Sulfacetamide

Reported adverse events (FAERS/openFDA)#

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