Application 217639

Type: NDA
Sponsor: STEMLINE THERAPEUTICS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORSERDU	ELACESTRANT	TABLET;ORAL	345MG	No	No
002	ORSERDU	ELACESTRANT	TABLET;ORAL	86MG	No	No

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
N217639-001	ORSERDU	ELACESTRANT HYDROCHLORIDE	EQ 86MG BASE	TABLET / ORAL		RLD	2023-01-27
N217639-002	ORSERDU	ELACESTRANT HYDROCHLORIDE	EQ 345MG BASE	TABLET / ORAL		RLD, RS	2023-01-27

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
N217639-001	7612114	2026-08-18	U-3523	Drug substance, Drug product	2023-03-10
N217639-001	10071066	2034-10-10	U-3524		2023-02-24
N217639-001	11779552	2034-10-10	U-3524		2023-11-06
N217639-001	10420734	2036-10-03	U-3524		2023-03-10
N217639-001	11819480	2037-02-28	U-3523		2023-12-21
N217639-001	10385008	2038-01-05		Drug substance, Drug product	2023-03-10
N217639-001	10745343	2038-01-05	U-3523		2023-02-24
N217639-002	7612114	2026-08-18	U-3523	Drug substance, Drug product	2023-03-10
N217639-002	10071066	2034-10-10	U-3524		2023-02-24
N217639-002	11779552	2034-10-10	U-3524		2023-11-06
N217639-002	10420734	2036-10-03	U-3524		2023-03-10
N217639-002	11819480	2037-02-28	U-3523		2023-12-21
N217639-002	10385008	2038-01-05		Drug substance, Drug product	2023-03-10
N217639-002	10745343	2038-01-05	U-3523		2023-02-24

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217639-001	NCE	2028-01-27
N217639-002	NCE	2028-01-27

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 · 46 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	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217639-001	ORSERDU	EQ 86MG BASE	TABLET / ORAL	RLD	2023-01-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217639-002	ORSERDU	EQ 345MG BASE	TABLET / ORAL	RLD, RS	2023-01-27	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 344 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	N217639-001	7612114	2026-08-18	U-3523	Drug substance, Drug product	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-001	10071066	2034-10-10	U-3524		2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-001	11779552	2034-10-10	U-3524		2023-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-001	10420734	2036-10-03	U-3524		2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-001	11819480	2037-02-28	U-3523		2023-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-001	10385008	2038-01-05		Drug substance, Drug product	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-001	10745343	2038-01-05	U-3523		2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	7612114	2026-08-18	U-3523	Drug substance, Drug product	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	10071066	2034-10-10	U-3524		2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	11779552	2034-10-10	U-3524		2023-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	10420734	2036-10-03	U-3524		2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	11819480	2037-02-28	U-3523		2023-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	10385008	2038-01-05		Drug substance, Drug product	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	10745343	2038-01-05	U-3523		2023-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	8399520	2025-12-25	U-3523	Drug substance, Drug product	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	7612114	2026-08-18	U-3523	Drug substance, Drug product	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	10071066	2034-10-10	U-3524		2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	11779552	2034-10-10	U-3524		2023-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	10420734	2036-10-03	U-3524		2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	11819480	2037-02-28	U-3523		2023-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	10385008	2038-01-05		Drug substance, Drug product	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	10745343	2038-01-05	U-3523		2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	8399520	2025-12-25	U-3523	Drug substance, Drug product	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	7612114	2026-08-18	U-3523	Drug substance, Drug product	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	10071066	2034-10-10	U-3524		2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	11779552	2034-10-10	U-3524		2023-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	10420734	2036-10-03	U-3524		2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	11819480	2037-02-28	U-3523		2023-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	10385008	2038-01-05		Drug substance, Drug product	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	10745343	2038-01-05	U-3523		2023-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217639-001	8399520	2025-12-25	U-3523	Drug substance, Drug product	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-001	7612114	2026-08-18	U-3523	Drug substance, Drug product	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-001	10071066	2034-10-10	U-3524		2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-001	10420734	2034-10-10	U-3524		2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-001	11779552	2034-10-10	U-3524		2023-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-001	11819480	2037-02-28	U-3523		2023-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-001	10385008	2038-01-05		Drug substance, Drug product	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-001	10745343	2038-01-05	U-3523		2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-002	8399520	2025-12-25	U-3523	Drug substance, Drug product	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-002	7612114	2026-08-18	U-3523	Drug substance, Drug product	2023-03-10	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217639-001	NCE	2028-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217639-002	NCE	2028-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-001	NCE	2028-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217639-002	NCE	2028-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217639-001	NCE	2028-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217639-002	NCE	2028-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217639-001	NCE	2028-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217639-002	NCE	2028-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217639-001	NCE	2028-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217639-002	NCE	2028-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217639-001	NCE	2028-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217639-002	NCE	2028-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217639-001	NCE	2028-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217639-002	NCE	2028-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217639-001	NCE	2028-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217639-002	NCE	2028-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217639-001	NCE	2028-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217639-002	NCE	2028-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217639-001	NCE	2028-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217639-002	NCE	2028-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217639-001	NCE	2028-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217639-002	NCE	2028-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217639-001	NCE	2028-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217639-002	NCE	2028-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217639-001	NCE	2028-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217639-002	NCE	2028-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217639-001	NCE	2028-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217639-002	NCE	2028-01-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217639-001	NCE	2028-01-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217639-002	NCE	2028-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217639-001	NCE	2028-01-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217639-002	NCE	2028-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217639-001	NCE	2028-01-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217639-002	NCE	2028-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217639-001	NCE	2028-01-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217639-002	NCE	2028-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217639-001	NCE	2028-01-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217639-002	NCE	2028-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217639-001	NCE	2028-01-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217639-002	NCE	2028-01-27	`a67488948f0b…`

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
ORSERDU	ELACESTRANT	Stemline Therapeutics, Inc.	aa66ae5c-2bd2-4444-8178-b55651e054ef	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217639 application number: NDA217639

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85110	ORIG	2026-02-24
76609	SUPPL	2026-02-24
76565	SUPPL	2023-11-14
73639	ORIG	2023-03-01
73328	ORIG	2023-01-30
73305	ORIG	2023-01-30