Application 088465

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	50MG	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
A088465-001	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL			1984-06-01

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088465-001	PREDNISONE	50MG	TABLET / ORAL	AB	1984-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088465-001	PREDNISONE	50MG	TABLET / ORAL	AB	1984-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088465-001	PREDNISONE	50MG	TABLET / ORAL	AB	1984-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088465-001	PREDNISONE	50MG	TABLET / ORAL	AB	1984-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088465-001	PREDNISONE	50MG	TABLET / ORAL		1984-06-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A088465-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A088465-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088465-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088465-001	AB	1	`ea99ee380514…`

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 13 · 245 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	REMEDYREPACK INC.	5218e88b-468b-4d60-ab7e-78cca632b23a	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	19fdbf9f-3a64-b9fa-e063-6394a90af086	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	1a9f00ac-ec92-4d2c-e063-6394a90ac4f6	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	25b5958b-c151-9200-e063-6394a90af52c	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	1349a022-639b-4494-99a2-1594c7c0f0e9	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	288ecb6d-3b0b-db95-e063-6394a90a78ff	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	Cardinal Health 107, LLC	cdc2b903-5d86-45c1-b97c-2da48445dbdd	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	6c0376c4-87cf-40dc-b140-a6aac75b64f7	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	931171e2-0bdb-451e-b737-72ce3ffbed53	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	55aedced-d945-4bd2-9aa8-0f18b89a0e7f	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	dc3bbb97-6588-46f4-b0ad-47596874ad0c	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	290a91e5-22ae-4d62-ab34-39a3117002e2	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	0062fcc7-aa08-4990-9d33-d798725907f1	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	Atlantic Biologicals Corps	07be390e-ef1e-4bf9-a9da-4338b5f6cfa5	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
Prednisone	PREDNISONE	ANI Pharmaceuticals, Inc.	f05eb734-07e7-491c-b2e9-aae340e03750	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Unit Dose Solutions, Inc.	5590d36d-dbe7-1c78-e063-6294a90ad2d4	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	03228706-92b9-43c9-8d73-c73aa124c58d	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	REMEDYREPACK INC.	746b0bcd-122e-4ea8-a824-28415073a38e	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	St. Mary's Medical Park Pharmacy	16ee689e-c7a9-3a5a-e063-6394a90a6ea2	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
prednisone	PREDNISONE	St. Mary's Medical Park Pharmacy	e4437eec-eadf-7c8b-e053-2a95a90af846	2026-06-21	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE