Home Applications 078465 Application 078465
Type ANDA
Sponsor PHARM ASSOC 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 10MG 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 A078465-001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078465-001 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 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078465-001 PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION / ORAL AA RS 2008-03-07 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0121-0773 Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate Pharmaceutical Associates, Inc. ANDA Current 0121-0773 Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate Pharmaceutical Associates, Inc. ANDA Current 0121-0773 Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate Pharmaceutical Associates, Inc. ANDA Current 23594-510 Millipred PREDNISOLONE SODIUM PHOSPHATE Zylera Pharmaceuticals, L ANDA Current 23594-510 Millipred PREDNISOLONE SODIUM PHOSPHATE Cerecor, Inc. ANDA Current