Application 078416

Type: ANDA
Sponsor: VINTAGE 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 5MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078416-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL			2007-10-31

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078416-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	2007-10-31	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 22 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	2026-07-09	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	Kesin Pharma	4c0dcbfd-2848-9bd0-e063-6394a90af5a7	2026-03-27	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	Preferred Pharmaceuticals, Inc.	93b372f7-b811-4c15-85c4-c6dbac342cb4	2025-09-10	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

Application 078416

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#