Application 091396

Type: ANDA
Sponsor: MISSION PHARMA

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 25MG 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
A091396-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091396-001	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	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL	AA	RS	2010-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091396-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 25MG BASE/5ML	SOLUTION / ORAL		RS	2010-09-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091396-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091396-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091396-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091396-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091396-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091396-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091396-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091396-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091396-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091396-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091396-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091396-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091396-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091396-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091396-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091396-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091396-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091396-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091396-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091396-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091396-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091396-001	AA	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091396-001	AA	1	`a50c72e98297…`

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 Oral Solution	PREDNISOLONE SODIUM PHOSPHATE	BioComp Pharma, Inc.	95208441-1700-5d3f-e053-2a95a90a7da2	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091396 application number: ANDA091396 ndc (product): 44523-182

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
0178-0582	Prednisolone Sodium Phosphate Oral Solution	Prednisolone Sodium Phosphate	Mission Pharmacal Company	ANDA	Current
44523-182	Prednisolone Sodium Phosphate Oral Solution	Prednisolone Sodium Phosphate	BioComp Pharma, Inc.	ANDA	Current
44523-182	Prednisolone Sodium Phosphate Oral Solution	Prednisolone Sodium Phosphate	BioComp Pharma, Inc.	ANDA	Current
44523-182	Prednisolone Sodium Phosphate Oral Solution	Prednisolone Sodium Phosphate	BioComp Pharma, Inc.	ANDA	Current