Application 083358

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.11% PHOSPHATE	No	No
002	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.9% PHOSPHATE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083358-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982
A083358-002	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC		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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083358-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.11% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A083358-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`f41ea6bd6efb…`

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 2 · 21 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	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Preferred Pharmaceuticals, Inc.	93b372f7-b811-4c15-85c4-c6dbac342cb4	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
PrednisoLONE Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	d1f937e7-fed5-4079-bd52-5d930b34ae9f	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: PrednisoLONE Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Chartwell RX, LLC.	2d8c861d-3756-4b75-aaa9-1b82cf11eb94	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	REMEDYREPACK INC.	f87ce1ba-335e-463d-87d5-9af0206f8f61	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Redpharm Drug	3253b63b-0533-6cdc-e063-6294a90aa311	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Edenbridge Pharmaceuticals LLC.	1793e218-7b49-497d-879f-1020de6e6d68	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Chartwell Governmental & Specialty RX, LLC.	5ec401b5-132a-4cd2-8c24-6a5c8b63c2f9	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate Oral Solution	PREDNISOLONE SODIUM PHOSPHATE	BioComp Pharma, Inc.	95208441-1700-5d3f-e053-2a95a90a7da2	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Preferred Pharmaceuticals Inc.	7262fc84-3db2-4475-8ae4-6bec4477cb81	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Atlantic Biologicals Corp	401f7ba6-a4a2-9ae6-e063-6394a90a4210	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	a0d74ae0-7b2d-4d36-9211-c76f5063b5a9	2025-07-10	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Orapred ODT	PREDNISOLONE SODIUM PHOSPHATE	Advanz Pharma (US) Corp.	1e379543-c4cf-4e72-953b-db15b7f0c2a1	2025-06-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Amneal Pharmaceuticals NY LLC	286a6032-41de-435a-b6e6-14052b66b85d	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	A-S Medication Solutions	4c507319-8add-4952-8bea-ff77ab17088f	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	acc8badf-d9fd-4f99-a650-a149138b68b1	2025-02-11	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	93cd0ddd-1cf5-4064-9a4c-015819c0065a	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Seton Pharmaceuticals, LLC	833ba492-8823-43b4-9a91-8b28d94a740b	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
prednisolone sodium phosphate ODT	PREDNISOLONE SODIUM PHOSPHATE	Ingenus Pharmaceuticals, LLC	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	2024-04-18	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	Bausch & Lomb Incorporated	8a7f0f2a-3a48-4488-89cd-3e91c3b1365f	2023-04-17	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE SODIUM PHOSPHATE generic name: PREDNISOLONE SODIUM PHOSPHATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.