FDA.reportPublic FDA data

Application 080751

Type
ANDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INFLAMASE MILDPREDNISOLONE SODIUM PHOSPHATESOLUTION/DROPS;OPHTHALMICEQ 0.11% PHOSPHATENoNo
002INFLAMASE FORTEPREDNISOLONE SODIUM PHOSPHATESOLUTION/DROPS;OPHTHALMICEQ 0.9% PHOSPHATENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080751-001INFLAMASE MILDPREDNISOLONE SODIUM PHOSPHATEEQ 0.11% PHOSPHATESOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982
A080751-002INFLAMASE FORTEPREDNISOLONE SODIUM PHOSPHATEEQ 0.9% PHOSPHATESOLUTION/DROPS / OPHTHALMICRLD, Approved 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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080751-001INFLAMASE MILDEQ 0.11% PHOSPHATESOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A080751-002INFLAMASE FORTEEQ 0.9% PHOSPHATESOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080751-001INFLAMASE MILDEQ 0.11% PHOSPHATESOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080751-002INFLAMASE FORTEEQ 0.9% PHOSPHATESOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080751-001INFLAMASE MILDEQ 0.11% PHOSPHATESOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080751-002INFLAMASE FORTEEQ 0.9% PHOSPHATESOLUTION/DROPS / OPHTHALMICRLD, Approved 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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEATLANTIC BIOLOGICALS CORP.96de9cad-2fb7-4947-87ae-4db57563a83a2026-09-04Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals, Inc.93b372f7-b811-4c15-85c4-c6dbac342cb42026-08-18Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
PrednisoLONE Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmad1f937e7-fed5-4079-bd52-5d930b34ae9f2026-06-25Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
prednisoLONE sodium phosphatePREDNISOLONE SODIUM PHOSPHATEKesin Pharma4c0dcbfd-2848-9bd0-e063-6394a90af5a72026-03-27Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEChartwell RX, LLC.2d8c861d-3756-4b75-aaa9-1b82cf11eb942026-02-13Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEREMEDYREPACK INC.f87ce1ba-335e-463d-87d5-9af0206f8f612026-02-10Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATERedpharm Drug3253b63b-0533-6cdc-e063-6294a90aa3112025-12-24Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEEdenbridge Pharmaceuticals LLC.1793e218-7b49-497d-879f-1020de6e6d682025-12-17Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEChartwell Governmental & Specialty RX, LLC.5ec401b5-132a-4cd2-8c24-6a5c8b63c2f92025-12-05Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate Oral SolutionPREDNISOLONE SODIUM PHOSPHATEBioComp Pharma, Inc.95208441-1700-5d3f-e053-2a95a90a7da22025-12-03Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals Inc.7262fc84-3db2-4475-8ae4-6bec4477cb812025-10-28Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEAtlantic Biologicals Corp401f7ba6-a4a2-9ae6-e063-6394a90a42102025-10-01Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmaa0d74ae0-7b2d-4d36-9211-c76f5063b5a92025-07-10Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Orapred ODTPREDNISOLONE SODIUM PHOSPHATEAdvanz Pharma (US) Corp.1e379543-c4cf-4e72-953b-db15b7f0c2a12025-06-03Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEAmneal Pharmaceuticals NY LLC286a6032-41de-435a-b6e6-14052b66b85d2025-04-29Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEA-S Medication Solutions4c507319-8add-4952-8bea-ff77ab17088f2025-02-28Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmaacc8badf-d9fd-4f99-a650-a149138b68b12025-02-11Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharma93cd0ddd-1cf5-4064-9a4c-015819c0065a2025-02-10Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATESeton Pharmaceuticals, LLC833ba492-8823-43b4-9a91-8b28d94a740b2024-09-23Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE
prednisolone sodium phosphate ODTPREDNISOLONE SODIUM PHOSPHATEIngenus Pharmaceuticals, LLCebbc1751-9381-4db1-89ff-ae5a2963fb2c2024-04-18Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE SODIUM PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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