Application 088810

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE INTENSOL	PREDNISONE	SOLUTION;ORAL	5MG/ML	No	Yes

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
A088810-001	PREDNISONE INTENSOL	PREDNISONE	5MG/ML	SOLUTION / ORAL		RLD, RS	1985-02-20

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RLD, RS	1985-02-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088810-001	PREDNISONE INTENSOL	5MG/ML	SOLUTION / ORAL	RS	1985-02-20	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE	PREDNISONE	Hikma Pharmaceuticals USA Inc.	3115aef0-fd50-4ec8-a064-3effb695f3f2	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088810 application number: ANDA088810 ndc (product): 0054-3721

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
0054-3721	PredniSONE Intensol	PredniSONE Intensol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3721	PredniSONE Intensol	PredniSONE Intensol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3721	PredniSONE Intensol	PredniSONE Intensol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3721	PredniSONE Intensol	PredniSONE Intensol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3721	PredniSONE Intensol	PredniSONE Intensol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3721	PredniSONE Intensol	PredniSONE Intensol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3721	PredniSONE Intensol	PredniSONE Intensol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3721	PredniSONE Intensol	PredniSONE Intensol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3721	PredniSONE Intensol	PredniSONE Intensol	Hikma Pharmaceuticals USA Inc.	ANDA	Current