Application 078988

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 20MG BASE/5ML	No	Yes

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
A078988-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078988-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078988-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	RS	2008-06-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078988-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078988-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078988-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078988-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078988-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078988-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078988-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078988-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078988-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078988-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078988-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078988-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078988-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078988-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078988-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078988-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078988-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078988-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078988-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078988-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078988-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078988-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078988-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078988-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078988-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078988-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078988-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078988-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078988-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078988-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078988-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078988-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078988-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078988-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078988-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078988-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078988-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078988-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078988-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078988-001	AA	1	`cb3db0bc1861…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	acc8badf-d9fd-4f99-a650-a149138b68b1	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078988 application number: ANDA078988 ndc (product): 0121-0777

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0777	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0777	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Pharmaceutical Associates, Inc.	ANDA	Current
23594-915	Veripred 20	PREDNISOLONE SODIUM PHOSPHATE	Zylera Pharmaceuticals, L	ANDA	Current
23594-915	Veripred 20	PREDNISOLONE SODIUM PHOSPHATE	Cerecor, Inc.	ANDA	Current
69101-410	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Burke Therapeutics	ANDA	Current
69101-410	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Burke Therapeutics	ANDA	Current
69101-410	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Burke Therapeutics	ANDA	Current
71626-902	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Medstone Pharma LLC	ANDA	Current
81646-118	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	PINNACLE PHARMA LLC	ANDA	Current