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 10 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	1b42449a-2be8-e4fb-e063-6394a90aff98	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	A-S Medication Solutions	3bfdc4d7-ba8e-422a-96e3-3c3ba587eab1	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	Direct_Rx	26194836-90c9-6909-e063-6294a90a6f98	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	81cef50e-394a-49b3-8723-28df68a742d6	2024-10-22	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	aaea2307-7893-48e9-af64-26172d08d4e8	2024-10-22	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	d40a97f6-60d1-4dbc-b4dc-650d82af5fae	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	90b8b43e-01f9-4503-91c4-2b3cbae91a83	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	f4cc64f8-781f-437a-a4a7-2d163026d1c2	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62fdf3c2-cfa9-d573-e053-2a91aa0a833b	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62ec965c-e682-9920-e053-2a91aa0adcdb	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	91167f27-6f36-4b89-a530-be26209e4301	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	NCS HealthCare of KY, LLC dba Vangard Labs	7b60255f-7d0b-4f91-a75c-6682ac446f6b	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Bryant Ranch Prepack	4433a882-ff79-4a9d-8db8-1977c5cd04cf	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Bryant Ranch Prepack	a2ba1a31-9e2d-4c1e-9bbd-b813831ce08f	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	62ff1da3-79aa-676a-e053-2991aa0a4a9f	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	1c59f8a1-e287-865f-e063-6394a90aa330	2024-07-03	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	1c33879e-8b2b-5843-e063-6294a90adea4	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	751b7f62-f92b-4b7c-a588-2c882d5d1ce3	2024-06-25	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Mylan Pharmaceuticals Inc.	fec09050-5ac2-451b-a2b9-5a21b2def212	2024-06-23	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Actavis Pharma, Inc.	aa0b1582-6ef3-4697-9ea6-5391e6e57853	2024-06-18	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.