FDA.reportPublic FDA data

Application 089047

Type
ANDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULF-15SULFACETAMIDE SODIUMSOLUTION/DROPS;OPHTHALMIC15%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089047-001SULF-15SULFACETAMIDE SODIUM15%SOLUTION/DROPS / OPHTHALMIC1995-10-31

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A089047-001SULF-1515%SOLUTION/DROPS / OPHTHALMIC1995-10-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089047-001SULF-1515%SOLUTION/DROPS / OPHTHALMIC1995-10-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089047-001SULF-1515%SOLUTION/DROPS / OPHTHALMIC1995-10-31a50c72e98297…

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 · 20 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
Sulfacetamide SodiumSULFACETAMIDE SODIUMA-S Medication Solutionsf212af23-be3d-4e82-9f6f-5ddce12a89da2026-03-23Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
OVACESULFACETAMIDE SODIUMMission Pharmacal Companya77aed6c-355f-44ed-ae95-78b4d1549c2b2026-01-08Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
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
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
SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMCintex Services, LLC214ff8a6-179f-b907-e063-6394a90adcb12024-09-04Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sulfacetamide SodiumSULFACETAMIDE SODIUMNuCare Pharmaceuticals,Inc.9910ec80-e37c-6a83-e053-2995a90a82372024-06-20Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMCintex Services, LLC0fa3302e-b2b4-6b9b-e063-6394a90abc2c2024-01-23Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sulfacetamide SodiumSULFACETAMIDE SODIUMBausch & Lomb Incorporated6c1b2658-e756-4f31-9bc8-f99a0baa46372023-08-31Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sulfacetamide SodiumSULFACETAMIDE SODIUMPadagis Israel Pharmaceuticals Ltd4fb4d39a-330e-4c84-abbc-3b33b36b206f2023-04-01Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sulfacetamide SodiumSULFACETAMIDE SODIUMAsclemed USA, Inc.c4c29e13-8303-4a9a-bb47-d7413eaf2f262022-10-12Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sulfacetamide SodiumSULFACETAMIDE SODIUMProficient Rx LP2b4f125c-338e-479f-8feb-b82324230c652022-08-01Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMKMM Pharmaceuticals, LLCcdb5b3dc-9f75-85b7-e053-2a95a90a380c2022-02-14Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
PLEXION NSSULFACETAMIDE SODIUMEckson Labs, LLCcdb4c921-e671-6f06-e053-2995a90abd1e2022-02-10Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
Sulfacetamide SodiumSULFACETAMIDE SODIUMAsclemed USA, Inc.129d5dd9-32a4-4398-862d-820cd44684482020-10-24Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM
KlaronSULFACETAMIDE SODIUMBausch Health US, LLC66ab38ea-5cea-47be-97f2-486517999fb02020-08-31Warnings, Adverse reactionsName fallback
generic name: SULFACETAMIDE SODIUM

Reported adverse events (FAERS/openFDA)#

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