Home Applications 084492 Application 084492
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREDNISOLONE ACETATE PREDNISOLONE ACETATE INJECTABLE;INJECTION 50MG/ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A084492-001 PREDNISOLONE ACETATE PREDNISOLONE ACETATE 50MG/ML INJECTABLE / INJECTION 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 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 A084492-001 PREDNISOLONE ACETATE 50MG/ML INJECTABLE / INJECTION Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A084492-001 PREDNISOLONE ACETATE 50MG/ML INJECTABLE / INJECTION Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A084492-001 PREDNISOLONE ACETATE 50MG/ML INJECTABLE / INJECTION Approved before 1982 a50c72e98297…
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 · 15 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PREDNISOLONE ACETATE PREDNISOLONE ACETATE A-S Medication Solutions dd32d625-fb2f-4c51-89fe-cdccdf0201b9 2026-08-03 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE Prednisolone Acetate PREDNISOLONE ACETATE Sportpharm LLC 3011a244-24a4-46ef-979a-b5d9e7076246 2026-07-23 Warnings, Adverse reactions Name fallback brand name: Prednisolone Acetate generic name: PREDNISOLONE ACETATE PREDNISOLONE ACETATE PREDNISOLONE ACETATE Sportpharm LLC 02fc6f0b-d053-49e1-82de-f272dd05d529 2026-04-24 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE PREDNISOLONE ACETATE PREDNISOLONE ACETATE A-S Medication Solutions f0e1b691-73ff-49ee-8a3c-71769b284ab8 2026-03-03 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE PREDNISOLONE ACETATE PREDNISOLONE ACETATE Redpharm Drug 3dd0195c-8522-bbf9-e063-6394a90a9f3e 2025-12-02 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE PRED MILD PREDNISOLONE ACETATE Allergan, Inc. 4fcce64a-94ea-4031-ad5a-c4eddc73a910 2025-11-25 Warnings, Adverse reactions Name fallback generic name: PREDNISOLONE ACETATE PREDNISOLONE ACETATE PREDNISOLONE ACETATE Lupin Pharmaceuticals, Inc. 75fbeab1-ce8d-4999-a875-472174be5cc6 2025-10-13 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE prednisolone acetate PREDNISOLONE ACETATE Amneal Pharmaceuticals NY LLC 8d8e8f9b-4d65-426f-8c57-451001cdd849 2025-06-12 Warnings, Adverse reactions Name fallback brand name: prednisolone acetate generic name: PREDNISOLONE ACETATE Prednisolone Acetate PREDNISOLONE ACETATE Sandoz Inc 05d205c7-8f51-46b9-a6c5-4199bc432b26 2024-12-30 Warnings, Adverse reactions Name fallback brand name: Prednisolone Acetate generic name: PREDNISOLONE ACETATE PREDNISOLONE ACETATE PREDNISOLONE ACETATE A-S Medication Solutions 388abc87-cd5a-4e88-8675-7bf0c5ce7af5 2024-10-14 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE PREDNISOLONE ACETATE PREDNISOLONE ACETATE NuCare Pharmaceuticals,Inc. ab72cf3d-7660-41b1-e053-2995a90a7f44 2024-07-17 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE PREDNISOLONE ACETATE PREDNISOLONE ACETATE Pacific Pharma, Inc. 1474d1df-70b6-4b1e-86d1-3349aa6d42fb 2024-03-19 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE PRED FORTE PREDNISOLONE ACETATE Allergan, Inc. 00a5aa88-e361-4ea7-8922-530c738b726e 2024-02-02 Warnings, Adverse reactions Name fallback generic name: PREDNISOLONE ACETATE Prednisolone Acetate PREDNISOLONE ACETATE A-S Medication Solutions b1d30a4f-4941-45a5-bd24-fea07f1bfc87 2023-04-30 Warnings, Adverse reactions Name fallback brand name: Prednisolone Acetate generic name: PREDNISOLONE ACETATE PREDNISOLONE ACETATE PREDNISOLONE ACETATE Asclemed USA, Inc. 232e40a5-17c5-4cf3-9e3b-110a194ad4be 2021-11-30 Warnings, Adverse reactions Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.