Application 203284

Type: NDA
Sponsor: HORIZON THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAVICTI	GLYCEROL PHENYLBUTYRATE	LIQUID;ORAL	1.1GM/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203284-001	RAVICTI	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203284-001	AA

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N203284-001	10045958	2030-09-22	U-1816	2018-08-22
N203284-001	10045959	2030-09-22	U-1816	2018-08-22
N203284-001	10183002	2030-09-22	U-1816	2019-02-21
N203284-001	10183003	2030-09-22	U-1816	2019-02-21
N203284-001	10183004	2030-09-22	U-1816	2019-02-21
N203284-001	10183005	2030-09-22	U-1816	2019-02-21
N203284-001	10183006	2030-09-22	U-1816	2019-02-21
N203284-001	10668040	2030-09-22	U-1816	2020-07-02
N203284-001	8642012	2030-09-22	U-1383	2014-02-27
N203284-001	9254278	2030-09-22	U-1816	2016-02-29
N203284-001	9326966	2030-09-22	U-1816	2016-05-25
N203284-001	9561197	2030-09-22	U-1383	2017-07-06
N203284-001	9962359	2030-09-22	U-1816	2018-06-07
N203284-001	9999608	2030-09-22	U-1816	2018-07-12

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 2 · 43 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	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL	AA	RLD, RS	2013-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203284-001	RAVICTI	1.1GM/ML	LIQUID / ORAL		RLD, RS	2013-02-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N203284-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203284-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203284-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203284-001	AA	1	`31067a03dcf5…`
2021-12-28 21:50 UTC	2021-12	N203284-001	AA	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203284-001	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 662 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203284-001	10045958	2030-09-22	U-1816	2018-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10045959	2030-09-22	U-1816	2018-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183002	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183003	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183004	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183005	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10183006	2030-09-22	U-1816	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	10668040	2030-09-22	U-1816	2020-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	8642012	2030-09-22	U-1383	2014-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9254278	2030-09-22	U-1816	2016-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9326966	2030-09-22	U-1816	2016-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9561197	2030-09-22	U-1383	2017-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9962359	2030-09-22	U-1816	2018-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203284-001	9999608	2030-09-22	U-1816	2018-07-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203284-001	10045958	2030-09-22	U-1816	2018-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10045959	2030-09-22	U-1816	2018-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183002	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183003	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183004	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183005	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10183006	2030-09-22	U-1816	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	10668040	2030-09-22	U-1816	2020-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	8642012	2030-09-22	U-1383	2014-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9254278	2030-09-22	U-1816	2016-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9326966	2030-09-22	U-1816	2016-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9561197	2030-09-22	U-1383	2017-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9962359	2030-09-22	U-1816	2018-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203284-001	9999608	2030-09-22	U-1816	2018-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10045958	2030-09-22	U-1816	2018-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10045959	2030-09-22	U-1816	2018-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183002	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183003	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183004	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183005	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10183006	2030-09-22	U-1816	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	10668040	2030-09-22	U-1816	2020-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	8642012	2030-09-22	U-1383	2014-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	9254278	2030-09-22	U-1816	2016-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	9326966	2030-09-22	U-1816	2016-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203284-001	9561197	2030-09-22	U-1383	2017-07-06	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203284-001	ODE-157	2024-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203284-001	ODE-157	2024-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203284-001	ODE-157	2024-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203284-001	ODE-157	2024-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203284-001	ODE-157	2024-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203284-001	ODE-157	2024-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203284-001	ODE-157	2024-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203284-001	ODE-157	2024-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203284-001	ODE-157	2024-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203284-001	ODE-157	2024-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203284-001	ODE-157	2024-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203284-001	ODE-157	2024-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203284-001	ODE-42	2020-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203284-001	NPP	2020-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203284-001	ODE-157	2024-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203284-001	ODE-157	2024-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203284-001	NPP	2021-12-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203284-001	ODE-157	2024-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203284-001	ODE-157	2024-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203284-001	ODE-157	2024-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203284-001	ODE-42	2020-02-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203284-001	NPP	2020-04-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203284-001	ODE-157	2024-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203284-001	ODE-42	2020-02-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203284-001	NPP	2020-04-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203284-001	ODE-157	2024-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203284-001	ODE-42	2020-02-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203284-001	NPP	2020-04-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203284-001	ODE-157	2024-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203284-001	ODE-42	2020-02-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203284-001	NPP	2020-04-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203284-001	ODE-157	2024-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203284-001	ODE-42	2020-02-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203284-001	NPP	2020-04-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203284-001	ODE-157	2024-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203284-001	ODE-157	2024-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203284-001	ODE-157	2024-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203284-001	ODE-157	2024-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203284-001	ODE-157	2024-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203284-001	ODE-157	2024-04-28	`9b2671bbb829…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ravicti	GLYCEROL PHENYLBUTYRATE	Horizon Therapeutics USA, Inc.	900e7dc0-9afe-4f50-80de-90567bb78519	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203284 application number: NDA203284 ndc (product): 75987-050
glycerol phenylbutyrate	GLYCEROL PHENYLBUTYRATE	Lupin Pharmaceuticals, Inc.	9bfa912f-c86c-4702-ac99-464c4356d80c	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203284 application number: NDA203284

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75987-050	Ravicti	glycerol phenylbutyrate	Horizon Therapeutics, Inc.	NDA	Current
75987-050	Ravicti	glycerol phenylbutyrate	Horizon Therapeutics, Inc.	NDA	Current
75987-050	Ravicti	glycerol phenylbutyrate	Horizon Therapeutics, Inc.	NDA	Current
75987-050	Ravicti	glycerol phenylbutyrate	Horizon Therapeutics, LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68580	SUPPL	2021-09-10
68577	SUPPL	2021-09-10
68551	SUPPL	2021-09-08
60482	SUPPL	2019-10-09
60252	SUPPL	2019-10-07
60251	SUPPL	2019-10-07
57063	SUPPL	2018-12-30
57029	SUPPL	2018-12-26
57028	SUPPL	2018-12-26
48283	SUPPL	2017-05-08
48181	SUPPL	2017-05-02
48174	SUPPL	2017-05-01
45291	SUPPL	2016-09-12
45266	SUPPL	2016-09-09
10194	SUPPL	2014-07-08
40285	SUPPL	2014-07-03
22919	ORIG	2013-03-28
40284	ORIG	2013-02-06
32405	ORIG	2013-02-04