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 4 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREDNISONE	PREDNISONE	Coupler LLC	50734a48-807d-cc00-e063-6294a90a4dae	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
prednisone	PREDNISONE	Sportpharm LLC	5dde7256-d3b8-400d-a0eb-c60078bfc5d9	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	0740ef68-7641-432e-bd46-4710687fc9d7	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	REMEDYREPACK INC.	4bd86b2f-75cb-4711-85e2-b81ed947cb13	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	e9a74862-6a3b-4247-837a-389761b5c352	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	b540f4af-8f07-4c56-b151-d759440c514a	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Bryant Ranch Prepack	70d05ed7-5c4e-4cd1-84cd-0dbe90692c54	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Northwind Health Company, LLC	fbd3f0c3-06b3-c9b4-e053-6294a90a6fdd	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e	2026-03-27	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	3befbdc5-7d20-41b6-ad80-98e1c6b8caf5	2026-03-27	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	A-S Medication Solutions	53c66f70-58fd-4d4c-b054-e5cefdc0c637	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	d6df3295-3118-49af-be05-b1fab0d4adaa	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	14d50f54-410b-45b2-a639-31498ceaf854	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	DIRECT RX	2a053775-6f6a-455e-b9a8-8b60e6062db3	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PREDNISONE	PREDNISONE	A-S Medication Solutions	e753e2bc-acca-46eb-888c-ae72fcac6ca4	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PREDNISONE	PREDNISONE	A-S Medication Solutions	a8f6298a-1084-4226-bfd9-a543a26ad2e7	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	852ea185-1bda-4c89-a192-ee0f93cba428	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	71295010-5adb-499b-a03a-5c78b5e79b2d	2026-03-07	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Asclemed USA, Inc.	fdcf3271-fae7-47ef-a370-adbdc0a3cf37	2026-03-03	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.