Application 210450

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORILISSA	ELAGOLIX SODIUM	TABLET;ORAL	EQ 150MG BASE	Yes	No
002	ORILISSA	ELAGOLIX SODIUM	TABLET;ORAL	EQ 200MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210450-001	ORILISSA	ELAGOLIX SODIUM	EQ 150MG BASE	TABLET / ORAL		RLD	2018-07-23
N210450-002	ORILISSA	ELAGOLIX SODIUM	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2018-07-23

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210450-001	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20
N210450-001	11707464	2034-03-14	U-3672		2023-08-23
N210450-001	10537572	2036-09-01	U-2735		2020-02-19
N210450-001	10682351	2036-09-01	U-2850		2020-07-15
N210450-001	11690854	2038-04-19	U-3653		2023-08-02
N210450-001	12102637	2038-08-20		Drug product	2024-10-29
N210450-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06
N210450-001	11690845	2040-08-27	U-3654		2023-08-02
N210450-002	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20
N210450-002	11344551	2034-03-14	U-3388		2022-06-27
N210450-002	11344551	2034-03-14	U-3389		2022-06-27
N210450-002	12102637	2038-08-20		Drug product	2024-10-29
N210450-002	11542239	2039-07-23		Drug substance, Drug product	2023-02-06
N210450-002	11690845	2040-08-27	U-3654		2023-08-02

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 550 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210450-001	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	11707464	2034-03-14	U-3672		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	10537572	2036-09-01	U-2735		2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	10682351	2036-09-01	U-2850		2020-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	11690854	2038-04-19	U-3653		2023-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	12102637	2038-08-20		Drug product	2024-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	11690845	2040-08-27	U-3654		2023-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	11344551	2034-03-14	U-3388		2022-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	11344551	2034-03-14	U-3389		2022-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	12102637	2038-08-20		Drug product	2024-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	11690845	2040-08-27	U-3654		2023-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	11707464	2034-03-14	U-3672		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	10537572	2036-09-01	U-2735		2020-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	10682351	2036-09-01	U-2850		2020-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	11690854	2038-04-19	U-3653		2023-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	12102637	2038-08-20		Drug product	2024-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	11690845	2040-08-27	U-3654		2023-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	11344551	2034-03-14	U-3388		2022-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	11344551	2034-03-14	U-3389		2022-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	12102637	2038-08-20		Drug product	2024-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	11690845	2040-08-27	U-3654		2023-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210450-001	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	11707464	2034-03-14	U-3672		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	10537572	2036-09-01	U-2735		2020-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	10682351	2036-09-01	U-2850		2020-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	11690854	2038-04-19	U-3653		2023-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	12102637	2038-08-20		Drug product	2024-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	11690845	2040-08-27	U-3654		2023-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	11344551	2034-03-14	U-3388		2022-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	11344551	2034-03-14	U-3389		2022-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	12102637	2038-08-20		Drug product	2024-10-29	`6a471c1ec25d…`

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
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210450-001	NCE	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210450-002	NCE	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210450-001	NCE	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210450-002	NCE	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210450-001	NCE	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210450-002	NCE	2023-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210450-001	NCE	2023-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210450-002	NCE	2023-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210450-001	NCE	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210450-002	NCE	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210450-001	NCE	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210450-002	NCE	2023-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210450-001	NCE	2023-07-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210450-002	NCE	2023-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210450-001	NCE	2023-07-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210450-002	NCE	2023-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210450-001	NCE	2023-07-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210450-002	NCE	2023-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210450-001	NCE	2023-07-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210450-002	NCE	2023-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210450-001	NCE	2023-07-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210450-002	NCE	2023-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210450-001	NCE	2023-07-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N210450-002	NCE	2023-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210450-001	NCE	2023-07-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N210450-002	NCE	2023-07-23	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N210450-001	NCE	2023-07-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N210450-002	NCE	2023-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210450-001	NCE	2023-07-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210450-002	NCE	2023-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210450-001	NCE	2023-07-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210450-002	NCE	2023-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210450-001	NCE	2023-07-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210450-002	NCE	2023-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210450-001	NCE	2023-07-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210450-002	NCE	2023-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210450-001	NCE	2023-07-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N210450-002	NCE	2023-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210450-001	NCE	2023-07-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N210450-002	NCE	2023-07-23	`3bdfa0b2c4d7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orilissa	ELAGOLIX	AbbVie Inc.	a86757b3-09c5-fd3b-1223-244e94f50a66	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210450 application number: NDA210450 ndc (product): 0074-0039 ndc (product): 0074-0038

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-0038	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0038	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0038	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0038	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0038	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0038	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0039	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0039	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0039	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0039	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0039	Orilissa	Elagolix	AbbVie Inc.	NDA	Current
0074-0039	Orilissa	Elagolix	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84467	SUPPL	2025-12-19
74447	SUPPL	2023-06-06
74438	SUPPL	2023-06-06
74437	SUPPL	2023-06-05
66105	SUPPL	2021-02-05
66104	SUPPL	2021-02-05
66103	SUPPL	2021-02-05
66102	SUPPL	2021-02-05
66101	SUPPL	2021-02-05
66100	SUPPL	2021-02-05
66079	SUPPL	2021-02-03
66078	SUPPL	2021-02-03
66077	SUPPL	2021-02-03
59891	SUPPL	2019-08-30
59878	SUPPL	2019-08-29
59877	SUPPL	2019-08-29
55267	ORIG	2018-08-22
54957	ORIG	2018-07-24
54956	ORIG	2018-07-24