Application 089247

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	20MG	No	No
002	PREDNISONE	PREDNISONE	TABLET;ORAL	5MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A089247-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04
A089247-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04
A089247-003	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A089247-001	AB
A089247-002	AB
A089247-003	AB

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 4 · 129 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
2026-09-14 22:38:34	2026-08	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089247-002	PREDNISONE	5MG	TABLET / ORAL	AB	1985-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089247-003	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089247-001	PREDNISONE	20MG	TABLET / ORAL	AB	1985-12-04	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A089247-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089247-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089247-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089247-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089247-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089247-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089247-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089247-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089247-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089247-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089247-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089247-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089247-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089247-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089247-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089247-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089247-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089247-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089247-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089247-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089247-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089247-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089247-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089247-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089247-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089247-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089247-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089247-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089247-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089247-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089247-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089247-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089247-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089247-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089247-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089247-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089247-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089247-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089247-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089247-001	AB	1	`301d65b070ca…`

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 5 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.	2760a808-b076-5887-e063-6294a90a79ae	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PREDNISONE	PREDNISONE	QPharma, Inc.	4aa286e3-e272-8095-e063-6394a90ae871	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PREDNISONE	PREDNISONE	ASCLEMED USA INC.	bf6ebe58-e7bb-49d3-842e-3372f8ba6172	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals, Inc.	292e2529-711c-7b74-e063-6394a90a660d	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
prednisone	PREDNISONE	Sportpharm LLC	0e3d2f62-2b02-4ddf-a983-abb71ff31e36	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	REMEDYREPACK INC.	ab9bffed-b1a2-4e82-ac45-bee40b41060f	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	Cardinal Health 107, LLC	199ed6a6-d9d9-49de-b383-5933a026591b	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	efe0c82b-9dd9-4729-b06f-06307867aca0	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Coupler LLC	47bb25d2-f33c-96ce-e063-6394a90a069e	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Northwind Health Company, LLC	f2a15b5d-f540-2582-e053-2995a90a591a	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Northwind Health Company, LLC	faf6c0c5-e5f4-4de5-e053-6294a90abd1a	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Northwind Health Company, LLC	f6cb7924-4190-f130-e053-6294a90a21fe	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Northwind Health Company, LLC	f2f1a2ea-fa1b-b4f1-e053-2995a90aa276	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	Northwind Health Company, LLC	ab315be2-8d13-be25-e053-2995a90a5184	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
Prednisone	PREDNISONE	Northwind Health Company, LLC	0f377d9f-b2f4-4dae-b503-5f963bea281f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	Northwind Health Company, LLC	dad4f191-8893-48e0-e053-2995a90ae864	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
PredniSONE	PREDNISONE	Northwind Health Company, LLC	ca39fdfb-d110-6535-e053-2995a90a550a	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
PredniSONE	PREDNISONE	Northwind Health Company, LLC	da6fce58-0ef9-f3b1-e053-2995a90a1bec	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
Prednisone	PREDNISONE	Northwind Health Company, LLC	da7f948f-8039-5f0d-e053-2a95a90ad0f0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Northwind Health Company, LLC	f7e523ab-d831-6acf-e053-6294a90a79a3	2026-01-01	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.