Application 213388

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORIAHNN	ELAGOLIX;ESTRADIOL NORETHINDRONE ACETATE;ELAGOLIX	CAPSULE;ORAL	300MG;1MG,0.5MG;300MG	Yes	No

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

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
N213388-001	ORIAHNN (COPACKAGED)	ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL		RLD, RS	2020-05-29

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02
N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29
N213388-001	10881659	2034-03-14	U-2842		2021-02-03
N213388-001	11045470	2034-03-14	U-2842		2021-07-27
N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08
N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06
N213388-001	11690845	2040-08-27	U-3655		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.

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	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 228 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	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	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	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	7056927	2024-09-10		Drug substance, Drug product	2020-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`03ed91905a0d…`

Observed Orange Book exclusivity history#

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	N213388-001	NP	2023-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213388-001	NCE	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213388-001	NP	2023-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213388-001	NCE	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213388-001	NP	2023-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213388-001	NCE	2023-07-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213388-001	NP	2023-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213388-001	NCE	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213388-001	NP	2023-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213388-001	NCE	2023-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213388-001	NP	2023-05-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213388-001	NCE	2023-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213388-001	NP	2023-05-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N213388-001	NCE	2023-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213388-001	NP	2023-05-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213388-001	NCE	2023-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213388-001	NP	2023-05-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N213388-001	NCE	2023-07-23	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N213388-001	NP	2023-05-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213388-001	NCE	2023-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213388-001	NP	2023-05-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213388-001	NCE	2023-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213388-001	NP	2023-05-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213388-001	NCE	2023-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213388-001	NP	2023-05-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213388-001	NCE	2023-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213388-001	NP	2023-05-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213388-001	NCE	2023-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213388-001	NP	2023-05-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213388-001	NCE	2023-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213388-001	NP	2023-05-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213388-001	NCE	2023-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213388-001	NP	2023-05-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213388-001	NCE	2023-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213388-001	NP	2023-05-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213388-001	NCE	2023-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213388-001	NP	2023-05-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N213388-001	NCE	2023-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213388-001	NP	2023-05-29	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213388-001	NCE	2023-07-23	`cb3db0bc1861…`

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
Oriahnn	ELAGOLIX AND ESTRADIOL AND NORETHISTERONE	AbbVie Inc.	99f6eee7-7e52-6999-7eb8-488d06dd1710	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213388 application number: NDA213388 ndc (product): 0074-1017

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-1017	Oriahnn	Elagolix and Estradiol and Norethisterone	AbbVie Inc.	NDA	Current
0074-1017	Oriahnn	Elagolix and Estradiol and Norethisterone	AbbVie Inc.	NDA	Current
0074-1017	Oriahnn	Elagolix and Estradiol and Norethisterone	AbbVie Inc.	NDA	Current
0074-1017	Oriahnn	Elagolix and Estradiol and Norethisterone	AbbVie Inc.	NDA	Current
0074-1017	Oriahnn	Elagolix and Estradiol and Norethisterone	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85844	SUPPL	2026-05-07
84466	SUPPL	2025-12-19
79890	SUPPL	2024-10-15
79884	SUPPL	2024-10-15
74444	SUPPL	2023-06-06
74440	SUPPL	2023-06-06
74439	SUPPL	2023-06-06
68389	SUPPL	2021-08-17
68276	SUPPL	2021-08-03
68275	SUPPL	2021-08-03
65154	ORIG	2020-11-04
63387	ORIG	2020-06-02
63377	ORIG	2020-06-02
63376	ORIG	2020-06-02