Application 202020

Type: NDA
Sponsor: HORIZON PHARMA USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAYOS	PREDNISONE	TABLET, DELAYED RELEASE;ORAL	1MG	Yes	No
002	RAYOS	PREDNISONE	TABLET, DELAYED RELEASE;ORAL	2MG	Yes	No
003	RAYOS	PREDNISONE	TABLET, DELAYED RELEASE;ORAL	5MG	Yes	Yes

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	RLD / RS	Approval date
N202020-001	RAYOS	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL	RLD	2012-07-26
N202020-002	RAYOS	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL	RLD	2012-07-26
N202020-003	RAYOS	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL	RLD	2012-07-26

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202020-001	9504699	2027-08-03	U-1362		2016-12-07
N202020-002	9504699	2027-08-03	U-1362		2016-12-07
N202020-003	9504699	2027-08-03	U-1362		2016-12-07
N202020-003	8168218	2028-01-07	U-1269	Drug product	2012-08-22

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2012-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL		RLD	2012-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2012-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2012-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202020-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202020-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202020-003	AB	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	N202020-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202020-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202020-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202020-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202020-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202020-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202020-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202020-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202020-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202020-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202020-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202020-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202020-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202020-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202020-003	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N202020-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202020-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202020-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N202020-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202020-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202020-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202020-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202020-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202020-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202020-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202020-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202020-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202020-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202020-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202020-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202020-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202020-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202020-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202020-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202020-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202020-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202020-001	AB	1	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 616 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202020-001	9504699	2027-08-03	U-1362		2016-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202020-002	9504699	2027-08-03	U-1362		2016-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202020-003	9504699	2027-08-03	U-1362		2016-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202020-003	8168218	2028-01-07	U-1269	Drug product	2012-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202020-001	9504699	2027-08-03	U-1362		2016-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202020-002	9504699	2027-08-03	U-1362		2016-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202020-003	9504699	2027-08-03	U-1362		2016-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202020-003	8168218	2028-01-07	U-1269	Drug product	2012-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202020-001	9504699	2027-08-03	U-1362		2016-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202020-002	9504699	2027-08-03	U-1362		2016-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202020-003	9504699	2027-08-03	U-1362		2016-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202020-003	8168218	2028-01-07	U-1269	Drug product	2012-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202020-001	9504699	2027-08-03	U-1362		2016-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202020-002	9504699	2027-08-03	U-1362		2016-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202020-003	9504699	2027-08-03	U-1362		2016-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202020-003	8168218	2028-01-07	U-1269	Drug product	2012-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202020-001	9504699	2027-08-03	U-1362		2016-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202020-002	9504699	2027-08-03	U-1362		2016-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202020-003	9504699	2027-08-03	U-1362		2016-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202020-003	8168218	2028-01-07	U-1269	Drug product	2012-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202020-001	9504699	2027-08-03	U-1362		2016-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202020-002	9504699	2027-08-03	U-1362		2016-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202020-003	9504699	2027-08-03	U-1362		2016-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202020-003	8168218	2028-01-07	U-1269	Drug product	2012-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202020-001	9504699	2027-08-03	U-1362		2016-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202020-002	9504699	2027-08-03	U-1362		2016-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202020-003	9504699	2027-08-03	U-1362		2016-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202020-003	8168218	2028-01-07	U-1269	Drug product	2012-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-001	8309124	2024-04-23	U-1292		2012-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-001	8394407	2024-04-23	U-1362	Drug product	2013-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-001	9040085	2024-04-23	U-1362		2015-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-001	9186332	2024-04-23	U-1362		2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-001	9504699	2027-08-03	U-1362		2016-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-002	8309124	2024-04-23				`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-002	8394407	2024-04-23	U-1362	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-002	9040085	2024-04-23	U-1362		2015-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-002	9186332	2024-04-23	U-1362		2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-002	9504699	2027-08-03	U-1362		2016-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-003	8309124	2024-04-23	U-1292			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-003	8394407	2024-04-23	U-1362	Drug product		`03ed91905a0d…`

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 7 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	QPharma, Inc.	d898d53f-c7d2-4bdb-bd9e-5f200070d123	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	475c6480-2a6a-4698-aff3-7affb154f2a7	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Strides Pharma Science Limited	a2c2e8ee-d222-47c5-93c2-8b44160a7e48	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	0e55a02d-2de4-42c4-adc2-49536b899225	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	61dab6c2-4019-4d7c-bc8b-3a0a463beefc	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	53bd04e8-6cbd-45f6-ac59-53fd3005a221	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	8520622e-c0e3-4226-be84-e332ab98e6a7	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	5e5c81bf-7cbb-4f02-b107-16efe3d353ee	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	QPharma, Inc.	c0e147a8-36a9-1e61-e053-2a95a90afd62	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Marlex Pharmaceuticals, Inc.	f499197b-b9b7-1707-e053-2a95a90a0932	2025-11-21	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	8f9a581c-5fef-4089-aa94-7dc81ec5b566	2025-11-10	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	871540d3-39c3-460c-a855-3aeabfd87267	2025-11-10	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	Coupler LLC	41e6f1c3-d225-0ff0-e063-6394a90ace88	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	83e825cc-fb19-48b9-9f15-6aba6b1cef57	2025-10-20	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	5b2f4fa9-817c-43c9-ac9a-750ab1d1f66f	2025-10-20	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	c21be016-6b25-4e09-b253-23b58884ccb6	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Direct_Rx	24882e23-c05f-f2ee-e063-6294a90a536f	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	80705a8a-f007-4a18-82a6-a73733d57ea2	2025-10-12	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	43a4b2eb-f2cd-410f-9719-577fdc4ad5de	2025-10-12	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	6f326242-786c-44b5-9317-f5fb0485d8e2	2025-10-12	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75987-020	RAYOS	prednisone	Horizon Pharma Inc.	NDA	Current
75987-020	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-020	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-020	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-020	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-021	RAYOS	prednisone	Horizon Pharma Inc.	NDA	Current
75987-021	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-021	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-021	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-021	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-022	RAYOS	prednisone	Horizon Pharma Inc.	NDA	Current
75987-022	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-022	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-022	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current
75987-022	RAYOS	prednisone	Horizon Therapeutics USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78722	SUPPL	2024-07-02
78684	SUPPL	2024-06-06
61503	SUPPL	2020-01-02
61476	SUPPL	2019-12-30
40094	SUPPL	2013-06-18
32152	SUPPL	2013-06-18
44839	ORIG	2013-05-24
22866	ORIG	2013-05-24
19045	ORIG	2012-07-30
9942	ORIG	2012-07-30