Application 076913

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 15MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076913-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076913-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA	RS	2005-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076913-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION / ORAL	AA		2005-04-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076913-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076913-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076913-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076913-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076913-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076913-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076913-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076913-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076913-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076913-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076913-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076913-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076913-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076913-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076913-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076913-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076913-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076913-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076913-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076913-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076913-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076913-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076913-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076913-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076913-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076913-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076913-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076913-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076913-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076913-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076913-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076913-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076913-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076913-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076913-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076913-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076913-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076913-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076913-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076913-001	AA	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Preferred Pharmaceuticals, Inc.	93b372f7-b811-4c15-85c4-c6dbac342cb4	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913 ndc (product): 68788-7708
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	REMEDYREPACK INC.	f87ce1ba-335e-463d-87d5-9af0206f8f61	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	a0d74ae0-7b2d-4d36-9211-c76f5063b5a9	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913 ndc (product): 0121-0759
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	A-S Medication Solutions	4c507319-8add-4952-8bea-ff77ab17088f	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913 ndc (product): 50090-1582
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Proficient Rx LP	14b7f41b-4df1-42cb-bd1b-c74b28de2670	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076913 application number: ANDA076913 ndc (product): 63187-215

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Pharmaceutical Associates, Inc.	ANDA	Current
17856-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Atlantic Biologicals Corps.	ANDA	Current
17856-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Atlantic Biologicals Corps.	ANDA	Current
17856-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Atlantic Biologicals Corps.	ANDA	Current
50090-1582	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	A-S Medication Solutions	ANDA	Current
50090-1582	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	A-S Medication Solutions	ANDA	Current
50090-1582	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	A-S Medication Solutions	ANDA	Current
50090-1582	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	A-S Medication Solutions	ANDA	Current
50436-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Unit Dose Services	ANDA	Current
50436-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Unit Dose Services	ANDA	Current
63187-215	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Proficient Rx LP	ANDA	Current
63187-215	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Proficient Rx LP	ANDA	Current
67296-1505	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	RedPharm Drug, Inc.	ANDA	Current
67296-1505	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	RedPharm Drug, Inc.	ANDA	Current
67296-1505	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	RedPharm Drug, Inc.	ANDA	Current
68151-0759	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Carilion Materials Management	ANDA	Current
68788-7708	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7708	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7708	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70166-549	Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	Lohxa	ANDA	Current