FDA.reportPublic FDA data

Application 080354

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISOLONEPREDNISOLONETABLET;ORAL5MGNoYes

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
A080354-001PREDNISOLONEPREDNISOLONE5MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A080354-001AB

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 22:54:322026-06A080354-001PREDNISOLONE5MGTABLET / ORALABRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A080354-001AB1a50c72e98297…

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisolonePREDNISOLONE ORALTulex Pharmaceuticals Inc757b41c4-a0fe-4a09-8816-a4cdb7558f412026-07-08Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PrednisolonePREDNISOLONEA-S Medication Solutions35f0b197-c3ae-445a-8da7-9ffcd4472e052026-01-23Warnings, Adverse reactionsName fallback
brand name: Prednisolone
generic name: PREDNISOLONE
PREDNISOLONEPREDNISOLONEZhejiang Xianju Pharmaceutical Co., Ltd.52e6e21d-94b8-41a0-8d13-371c0e66bcee2026-01-05Warnings, Adverse reactionsName fallback
brand name: PREDNISOLONE
generic name: PREDNISOLONE
PrednisolonePREDNISOLONE ORALChartwell Governmental & Specialty RX, LLC.2dac9898-6492-4f34-ad86-83a902e0fe0b2025-11-18Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PrednisolonePREDNISOLONE ORAL SOLUTIONHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.b079834f-9aa3-4db9-bd53-de28e8f81c042025-02-18Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PrednisolonePREDNISOLONEPAI Holdings, LLC dba PAI Pharmacebd7b5b-8e9f-4de9-9fcf-8ee0661fede32024-08-19Warnings, Adverse reactionsName fallback
brand name: Prednisolone
generic name: PREDNISOLONE
PREDNISOLONEPREDNISOLONEHisun Pharmaceuticals USA, Inc.16d4e064-66d3-4497-8c7d-3aa355f91e1d2024-08-15Warnings, Adverse reactionsName fallback
brand name: PREDNISOLONE
generic name: PREDNISOLONE
PrednisolonePREDNISOLONEChartwell RX, LLC2e965355-f7f2-4dd3-9c5c-1524c6f39c912024-06-17Warnings, Adverse reactionsName fallback
brand name: Prednisolone
generic name: PREDNISOLONE
PrednisolonePREDNISOLONE ORALChartwell RX, LLCaa40f582-cced-4e6e-90f0-10ab310ab2a72024-06-03Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PREDNISOLONEPREDNISOLONEAurobindo Pharma Limited070f1937-50a5-457f-bef5-4e597014e26d2024-02-16Warnings, Adverse reactionsName fallback
brand name: PREDNISOLONE
generic name: PREDNISOLONE
PrednisoLONEPREDNISOLONELannett Company, Inc.86652e2d-664a-4388-a611-c2a9aa4a4bc82024-02-14Warnings, Adverse reactionsName fallback
brand name: PrednisoLONE
generic name: PREDNISOLONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23594-505MILLIPREDPREDNISOLONECerecor, Inc.ANDACurrent
23594-505MILLIPREDPREDNISOLONEAytu TherapeuticsANDACurrent
23594-505MILLIPREDPREDNISOLONEAytu TherapeuticsANDACurrent
23594-505MILLIPREDPREDNISOLONEZylera Pharmaceuticals, LANDACurrent
73534-505MILLIPREDPREDNISOLONEAvalo Therapeutics Inc.ANDACurrent