Home Applications 019157 Application 019157
Type NDA
Sponsor SETON PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PEDIAPRED PREDNISOLONE SODIUM PHOSPHATE SOLUTION;ORAL EQ 5MG BASE/5ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N019157-001 PEDIAPRED PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019157-001 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 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019157-001 PEDIAPRED EQ 5MG BASE/5ML SOLUTION / ORAL AA RLD, RS 1986-05-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 2 matching rows.
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 0121-0902 Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate Pharmaceutical Associates, Inc. NDA Current 13925-166 Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate Seton Pharmaceuticals, LLC NDA Current 13925-166 Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate Seton Pharmaceuticals, LLC NDA Current 68791-104 PEDIAPRED Prednisolone Sodium Phosphate Royal Pharmaceuticals NDA Current 68791-104 PEDIAPRED Prednisolone Sodium Phosphate Royal Pharmaceuticals NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78717 SUPPL 2024-06-07 78682 SUPPL 2024-06-06 52514 SUPPL 2018-02-08 52431 SUPPL 2018-02-06 33702 SUPPL 2013-10-17 1245 SUPPL 2013-10-10 40876 ORIG 2007-04-11 20211 SUPPL 2006-05-08 11443 SUPPL 2004-12-08 1244 SUPPL 2004-12-08 40877 SUPPL 2003-09-11 16207 SUPPL 1998-12-17 1243 SUPPL 1998-12-17 1242 SUPPL 1998-12-17 1241 SUPPL 1998-12-17