Application 203559

Type: ANDA
Sponsor: EDENBRIDGE PHARMS

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	No
002	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION;ORAL	EQ 20MG BASE/5ML	No	No
003	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION;ORAL	EQ 15MG BASE/5ML	No	No
004	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION;ORAL	EQ 25MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203559-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20
A203559-002	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20
A203559-003	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06
A203559-004	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203559-001	AA
A203559-002	AA
A203559-003	AA
A203559-004	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 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2016-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203559-004	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	2023-02-06	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A203559-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203559-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203559-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203559-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203559-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203559-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203559-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203559-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203559-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203559-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203559-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203559-002	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203559-003	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203559-004	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203559-001	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203559-002	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203559-003	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203559-004	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203559-001	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203559-002	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203559-003	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203559-004	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203559-001	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203559-002	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203559-003	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203559-004	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203559-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203559-002	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203559-003	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203559-004	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203559-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203559-002	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203559-003	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203559-004	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203559-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203559-002	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203559-003	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203559-004	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203559-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203559-002	AA	1	`053a50430f4f…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	ATLANTIC BIOLOGICALS CORP.	96de9cad-2fb7-4947-87ae-4db57563a83a	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559
prednisoLONE sodium phosphate	PREDNISOLONE SODIUM PHOSPHATE	Kesin Pharma	4c0dcbfd-2848-9bd0-e063-6394a90af5a7	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Redpharm Drug	3253b63b-0533-6cdc-e063-6294a90aa311	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Edenbridge Pharmaceuticals LLC.	1793e218-7b49-497d-879f-1020de6e6d68	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559 ndc (product): 42799-813 ndc (product): 42799-812
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Preferred Pharmaceuticals Inc.	7262fc84-3db2-4475-8ae4-6bec4477cb81	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Atlantic Biologicals Corp	401f7ba6-a4a2-9ae6-e063-6394a90a4210	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203559 application number: ANDA203559

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
42799-812	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Edenbridge Pharmaceuticals, LLC	ANDA	Current
42799-812	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Edenbridge Pharmaceuticals LLC.	ANDA	Current
42799-813	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Edenbridge Pharmaceuticals, LLC	ANDA	Current
42799-813	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Edenbridge Pharmaceuticals LLC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46522	ORIG	2016-12-23