Application 022474

Type: NDA
Sponsor: LAB HRA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELLA	ULIPRISTAL ACETATE	TABLET;ORAL	30MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022474-001	ELLA	ULIPRISTAL ACETATE	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022474-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022474-001	9844510	2028-12-08		Drug product	2019-04-18
N022474-001	8735380	2029-02-20		Drug product	2014-06-13
N022474-001	10159681	2030-04-13	U-2510		2019-04-18
N022474-001	10772897	2030-04-13	U-2958		2020-10-14
N022474-001	9283233	2030-04-13	U-1821		2016-03-16
N022474-001	8512745	2030-06-02		Drug product	2013-09-12
N022474-001	8426392	2030-06-12	U-1389		2013-05-07
N022474-001	8962603	2030-06-12	U-1657		2015-02-25

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 · 42 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	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022474-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022474-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022474-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022474-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022474-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022474-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022474-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022474-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022474-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022474-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022474-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022474-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022474-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022474-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022474-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022474-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022474-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022474-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022474-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022474-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022474-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022474-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022474-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022474-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022474-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022474-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022474-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022474-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022474-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022474-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022474-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022474-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022474-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022474-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022474-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022474-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022474-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022474-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 331 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	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`fd3edfee7708…`

Observed Orange Book exclusivity history#

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	N022474-001	M-271	2024-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022474-001	M-271	2024-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022474-001	M-271	2024-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022474-001	M-271	2024-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022474-001	M-271	2024-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022474-001	M-271	2024-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022474-001	M-271	2024-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022474-001	M-271	2024-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022474-001	M-271	2024-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022474-001	M-271	2024-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022474-001	M-271	2024-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022474-001	M-271	2024-06-24	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022474-001	M-271	2024-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022474-001	M-271	2024-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022474-001	M-271	2024-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022474-001	M-271	2024-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022474-001	M-271	2024-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022474-001	M-271	2024-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022474-001	M-271	2024-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022474-001	M-271	2024-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022474-001	M-271	2024-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022474-001	M-271	2024-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022474-001	M-271	2024-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022474-001	M-271	2024-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022474-001	M-271	2024-06-24	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ella	ULIPRISTAL ACETATE	PMI Branded Pharmaceuticals, Inc.	2bf93d23-cddd-4613-9066-5b5fa090404b	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022474 application number: NDA022474 ndc (product): 73302-456
Ella	ULIPRISTAL ACETATE	A-S Medication Solutions	e5f09468-7ac8-40ba-a85b-758a32f586c3	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022474 application number: NDA022474 ndc (product): 50090-5422

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2835	Ella	ulipristal acetate	A-S Medication Solutions	NDA	Current
50090-2835	Ella	ulipristal acetate	A-S Medication Solutions	NDA	Current
50090-5422	Ella	ulipristal acetate	A-S Medication Solutions	NDA	Current
50102-911	Ella	ulipristal acetate	Afaxys Pharma LLC	NDA	Current
50102-911	Ella	ulipristal acetate	Afaxys Pharma LLC	NDA	Current
53002-1630	Ella	ulipristal acetate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1630	Ella	ulipristal acetate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-2630	Ella	ulipristal acetate	RPK Pharmaceuticals, Inc.	NDA	Current
73302-456	Ella	ulipristal acetate	HRA Pharma America, Inc.	NDA	Current
73302-456	Ella	ulipristal acetate	HRA Pharma America, Inc.	NDA	Current
82454-0456	Ella	ulipristal acetate	CENEXI HSC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67919	SUPPL	2021-06-28
67901	SUPPL	2021-06-25
54013	SUPPL	2018-05-04
54000	SUPPL	2018-05-03
22032	SUPPL	2015-03-31
17633	SUPPL	2015-03-12
7450	SUPPL	2015-03-11
29768	SUPPL	2014-09-03
38755	SUPPL	2014-08-28
17632	SUPPL	2014-06-17
7449	SUPPL	2014-06-17
38754	SUPPL	2012-05-07
7448	SUPPL	2012-05-04
24318	ORIG	2010-09-17
22031	ORIG	2010-09-17
38753	ORIG	2010-08-13
7447	ORIG	2010-08-13
54135	ORIG	1900-01-01
54134	ORIG	1900-01-01
54133	ORIG	1900-01-01
54132	ORIG	1900-01-01