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 12 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	A-S Medication Solutions	17278e0a-cbff-4a95-96ee-f34f7466faa0	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Chartwell RX, LLC	92483276-d55c-42c6-8bbc-27137ff25296	2023-09-06	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Proficient Rx LP	6a0c1192-8ce4-466d-a0f3-d878d67349cf	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	5961b1d4-6a4c-452f-b3f1-c99f3a9a6445	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	A-S Medication Solutions	0060b86b-0b79-4c54-a7be-97683a933a05	2023-08-31	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
PredniSONE	PREDNISONE	A-S Medication Solutions	f11c190e-edf8-454d-82c4-1ed769b5a6d2	2023-08-31	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
PredniSONE	PREDNISONE	A-S Medication Solutions	6f0719a2-1759-4354-9363-bb9fb3bddb3d	2023-08-31	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
prednisone	PREDNISONE	Proficient Rx LP	6ec5b58c-65e9-47ee-b2ac-7d0b395a0630	2023-07-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Proficient Rx LP	22d9fd96-cad5-4762-9a56-0ff63357ed9e	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	NCS HealthCare of KY, LLC dba Vangard Labs	bc37cc2e-2f6a-4131-bb6a-63b6e576df21	2022-11-11	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	NCS HealthCare of KY, LLC dba Vangard Labs	202f6840-f3bd-4bed-ab5d-b36d3c4cdf0f	2022-11-10	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	PharmPak, Inc.	03aaf69f-d9c7-433c-baea-9c6eca0fe1e5	2022-10-08	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	71d70ec6-859a-4951-af98-248a864e1135	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	Proficient Rx LP	e109f428-ca85-4a2c-acd0-ca8d498e7723	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	67681e4e-3002-4428-af5e-6ff1a950b037	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	a1bff575-cd79-4596-99f1-30a5fe8a8b4c	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	35f504c3-1cf5-455d-8226-9ffeea606623	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	016d65c3-fff2-4e0c-9025-e2083cfa6a1f	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	7d52bf53-76e3-4826-a12b-b16a8560bafc	2021-05-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Asclemed USA, Inc.	dc663fd3-b149-48ae-a3f3-6abaa4808cc6	2020-08-28	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.