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 42.

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 · 126 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
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202020-002	RAYOS	2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202020-003	RAYOS	5MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2012-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202020-001	RAYOS	1MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2012-07-26	`1e350fbaab3a…`

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 · 612 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-003	9040085	2024-04-23	U-1362		2015-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-003	9186332	2024-04-23	U-1362		2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202020-003	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	8168218	2028-01-07	U-1269	Drug product	2012-08-22	`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 1 of 13 · 246 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	REMEDYREPACK INC.	23b12d22-97d6-426e-bf9c-dd6c2ff77370	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	6b360c1f-c862-47ee-a40e-3903c2d6162f	2026-08-21	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE	PREDNISONE	Preferred Pharmaceuticals Inc.	02158832-550b-4855-a5c5-6abbf13ed6f0	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	c60a07f9-ed9f-4434-a69d-2e2fea4843fd	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	REMEDYREPACK INC.	746b0bcd-122e-4ea8-a824-28415073a38e	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	7ea7f6a9-78ef-42fe-baac-f817da3976fb	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	fa75f5ce-8a74-4873-811f-7d9d9beec08f	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	930b5eea-3ec8-47df-a76d-1e0bc0b5c5b2	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Preferred Pharmaceuticals, Inc.	f89bd1dc-88cd-4aef-a7ae-6310f38a3423	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	ce7663a7-4c91-4790-aa43-96f259b3bb18	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	e47a0448-331f-4846-8e63-c52c3afa274b	2026-08-11	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Cardinal Health 107, LLC	568b8880-7997-4786-8c57-28816ce52655	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	af5d0f73-2aef-4db1-ae25-6d465c9f0ca1	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Par Health USA, LLC	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	2026-07-31	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	5218e88b-468b-4d60-ab7e-78cca632b23a	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	19fdbf9f-3a64-b9fa-e063-6394a90af086	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	1a9f00ac-ec92-4d2c-e063-6394a90ac4f6	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	25b5958b-c151-9200-e063-6394a90af52c	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	1349a022-639b-4494-99a2-1594c7c0f0e9	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE

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