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 6 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Northwind Health Company, LLC	f76db82a-826e-92b0-e053-6294a90a8ec6	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	Northwind Health Company, LLC	f77f4a5a-b307-84ff-e053-6294a90aba5b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
prednisone	PREDNISONE	Northwind Health Company, LLC	e08ba8c5-5e26-6120-e053-2995a90a1364	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	Northwind Health Company, LLC	c9f4711d-319c-d952-e053-2a95a90a3697	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
prednisone	PREDNISONE	Northwind Health Company, LLC	fc4cd6f4-e01f-ad2d-e053-6294a90aebd6	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	American Health Packaging	5393d51e-816b-4761-8e8a-7eadcf74245f	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Redpharm Drug	0ab0e81c-8170-6805-e063-6294a90adfc0	2025-12-25	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	American Health Packaging	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	e28359cf-0c21-487a-a1a3-d1c62cef88f9	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	A-S Medication Solutions	35de14e3-d748-46bd-a307-6a1a27c626a2	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone delayed release	PREDNISONE	INA Pharmaceutics Inc	463c7cd2-c973-5c6c-e063-6394a90a09a0	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone delayed release	PREDNISONE	Dr. Reddys Laboratories Inc.	01bdc479-1f1f-af94-837c-12e7e861321a	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Strides Pharma Science Limited	2ef05381-faad-4e0f-b58d-9f2236a04a2c	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	Redpharm Drug	44f5e966-5a12-e2ff-e063-6294a90a919e	2025-12-13	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	Chartwell RX, LLC	36631112-3abb-4003-886b-9fe6d9cbe2cc	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Chartwell RX, LLC	f532c919-765d-407a-9e01-db2dc0c006f5	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Strides Pharma Science Limited	52010a34-aadb-4561-ac4a-3ee53f5e3566	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	QPharma, Inc.	318fdf0d-c03a-4b48-a380-b7bb630363fb	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
Prednisone	PREDNISONE	QPharma, Inc.	07fb8daa-2ceb-4564-b0d0-6cdf903da0b5	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	QPharma, Inc.	f4d5974a-444f-4ef0-84a9-803150ccdeac	2025-12-03	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.