FDA.reportPublic FDA data

Application 078416

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATESOLUTION;ORALEQ 5MG BASE/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078416-001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATEEQ 5MG BASE/5MLSOLUTION / ORAL2007-10-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078416-001PREDNISOLONE SODIUM PHOSPHATEEQ 5MG BASE/5MLSOLUTION / ORAL2007-10-31a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-4db57563a83a2026-07-09Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
PrednisoLONE Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmad1f937e7-fed5-4079-bd52-5d930b34ae9f2026-06-25Warnings, Adverse reactionsName fallback
brand name: PrednisoLONE Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
prednisoLONE sodium phosphatePREDNISOLONE SODIUM PHOSPHATEKesin Pharma4c0dcbfd-2848-9bd0-e063-6394a90af5a72026-03-27Warnings, Adverse reactionsName fallback
brand name: prednisoLONE sodium phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEChartwell RX, LLC.2d8c861d-3756-4b75-aaa9-1b82cf11eb942026-02-13Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEREMEDYREPACK INC.f87ce1ba-335e-463d-87d5-9af0206f8f612026-02-10Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATERedpharm Drug3253b63b-0533-6cdc-e063-6294a90aa3112025-12-24Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEEdenbridge Pharmaceuticals LLC.1793e218-7b49-497d-879f-1020de6e6d682025-12-17Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEChartwell Governmental & Specialty RX, LLC.5ec401b5-132a-4cd2-8c24-6a5c8b63c2f92025-12-05Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
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
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEAtlantic Biologicals Corp401f7ba6-a4a2-9ae6-e063-6394a90a42102025-10-01Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals, Inc.93b372f7-b811-4c15-85c4-c6dbac342cb42025-09-10Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmaa0d74ae0-7b2d-4d36-9211-c76f5063b5a92025-07-10Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
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
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEA-S Medication Solutions4c507319-8add-4952-8bea-ff77ab17088f2025-02-28Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmaacc8badf-d9fd-4f99-a650-a149138b68b12025-02-11Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharma93cd0ddd-1cf5-4064-9a4c-015819c0065a2025-02-10Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATESeton Pharmaceuticals, LLC833ba492-8823-43b4-9a91-8b28d94a740b2024-09-23Warnings, Adverse reactionsName fallback
brand name: Prednisolone Sodium Phosphate
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