Application 089983

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089983-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL			1989-01-12

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089983-001	PREDNISONE	10MG	TABLET / ORAL	1989-01-12	`f41ea6bd6efb…`

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 7 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	QPharma, Inc.	d898d53f-c7d2-4bdb-bd9e-5f200070d123	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	475c6480-2a6a-4698-aff3-7affb154f2a7	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Strides Pharma Science Limited	a2c2e8ee-d222-47c5-93c2-8b44160a7e48	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	0e55a02d-2de4-42c4-adc2-49536b899225	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	61dab6c2-4019-4d7c-bc8b-3a0a463beefc	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	53bd04e8-6cbd-45f6-ac59-53fd3005a221	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	8520622e-c0e3-4226-be84-e332ab98e6a7	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	5e5c81bf-7cbb-4f02-b107-16efe3d353ee	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	QPharma, Inc.	c0e147a8-36a9-1e61-e053-2a95a90afd62	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Marlex Pharmaceuticals, Inc.	f499197b-b9b7-1707-e053-2a95a90a0932	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	8f9a581c-5fef-4089-aa94-7dc81ec5b566	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	871540d3-39c3-460c-a855-3aeabfd87267	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	Coupler LLC	41e6f1c3-d225-0ff0-e063-6394a90ace88	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	83e825cc-fb19-48b9-9f15-6aba6b1cef57	2025-10-20	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	5b2f4fa9-817c-43c9-ac9a-750ab1d1f66f	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
PREDNISONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	c21be016-6b25-4e09-b253-23b58884ccb6	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	Direct_Rx	24882e23-c05f-f2ee-e063-6294a90a536f	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	80705a8a-f007-4a18-82a6-a73733d57ea2	2025-10-12	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	43a4b2eb-f2cd-410f-9719-577fdc4ad5de	2025-10-12	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	6f326242-786c-44b5-9317-f5fb0485d8e2	2025-10-12	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.