Home Applications 091396 Application 091396
Type ANDA
Sponsor MISSION PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION;ORAL EQ 25MG BASE/5ML No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A091396-001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091396-001 AA
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 · 44 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 2022-10-28 04:53 UTC 2022-10 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL RS 2010-09-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091396-001 PREDNISOLONE SODIUM PHOSPHATE EQ 25MG BASE/5ML SOLUTION / ORAL AA RS 2010-09-13 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0178-0582 Prednisolone Sodium Phosphate Oral Solution Prednisolone Sodium Phosphate Mission Pharmacal Company ANDA Current 44523-182 Prednisolone Sodium Phosphate Oral Solution Prednisolone Sodium Phosphate BioComp Pharma, Inc. ANDA Current 44523-182 Prednisolone Sodium Phosphate Oral Solution Prednisolone Sodium Phosphate BioComp Pharma, Inc. ANDA Current 44523-182 Prednisolone Sodium Phosphate Oral Solution Prednisolone Sodium Phosphate BioComp Pharma, Inc. ANDA Current