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 9 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	30956dd5-fe19-d5a9-e063-6394a90a2549	2025-04-04	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	NuCare Pharmaceuticals, Inc.	31cfc21f-726b-ae80-e063-6294a90a9af4	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Proficient Rx LP	c2f477da-0b99-4fc4-89ca-94831de950a3	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Bryant Ranch Prepack	9a2d3bee-610b-44dc-8266-869aaf08f0d1	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	309580a7-c3bb-e53b-e063-6394a90a1563	2025-03-17	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Bryant Ranch Prepack	f0354431-4968-4e34-969b-6985d73700a4	2025-02-25	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	1cb252f0-fd01-4620-bf88-2108fc1ea615	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e62cf2e-dcbe-c15e-e063-6294a90a8168	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
PREDNISONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e62cf2e-dcbf-c15e-e063-6294a90a8168	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PredniSONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e630aa1-eccd-f5eb-e063-6294a90a4745	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
Prednisone	PREDNISONE	Coupler LLC	2d99223a-853a-7640-e063-6394a90a260a	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	Preferred Pharmaceuticals Inc.	94d82acb-ff31-492f-bd51-b23e15d881d6	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	Direct_Rx	fd8eb82e-52df-c368-e053-6294a90ac6b0	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	af863b9e-964b-3b1e-e053-2995a90ab93a	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	af861c38-3293-13fe-e053-2995a90a9932	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	b3dbf833-b929-8c85-e053-2995a90a5896	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	e1e7d14b-80b2-f57e-e053-2995a90af112	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Advanced Rx Pharmacy of Tennessee, LLC	b3dbff9f-610f-7782-e053-2a95a90a71c1	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals, Inc.	28f2733e-963e-f0e0-e063-6394a90a0a9d	2024-12-10	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.