Application 213793

Type: NDA
Sponsor: RHYTHM PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMCIVREE	SETMELANOTIDE	SOLUTION;SUBCUTANEOUS	10MG/ML	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
N213793-001	IMCIVREE	SETMELANOTIDE ACETATE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2020-11-25

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22
N213793-001	8039435	2032-08-21	Drug substance, Drug product	2020-12-22
N213793-001	11129869	2034-07-04	Drug product	2021-10-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213793-001	ODE-336	2027-11-25
N213793-001	NPP	2027-12-20
N213793-001	I-987	2029-03-19
N213793-001	ODE-402	2029-06-16
N213793-001	ODE-508	2031-12-20
N213793-001	ODE-509	2031-12-20

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	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213793-001	IMCIVREE	EQ 10MG/ML BASE (EQ 10MG/ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213793-001	IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	8039435	2032-08-21	Drug substance, Drug product	2020-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	8039435	2032-08-21	Drug substance, Drug product	2020-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	8039435	2032-08-21	Drug substance, Drug product	2020-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213793-001	9458195	2027-10-13	Drug substance, Drug product	2020-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213793-001	11129869	2034-07-04	Drug product	2021-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213793-001	8039435	2027-10-13	Drug substance, Drug product	2020-12-22	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 130 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	N213793-001	ODE-336	2027-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	NPP	2027-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	ODE-402	2029-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	ODE-508	2031-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213793-001	ODE-509	2031-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	I-892	2025-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	NCE	2025-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	ODE-336	2027-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	NPP	2027-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	ODE-402	2029-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	ODE-508	2031-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213793-001	ODE-509	2031-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213793-001	I-892	2025-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	NCE	2025-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	ODE-336	2027-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	NPP	2027-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	ODE-402	2029-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	ODE-508	2031-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213793-001	ODE-509	2031-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	I-892	2025-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	NCE	2025-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	ODE-336	2027-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	NPP	2027-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213793-001	ODE-402	2029-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	I-892	2025-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	NCE	2025-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	ODE-336	2027-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	NPP	2027-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213793-001	ODE-402	2029-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	I-892	2025-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	NCE	2025-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	ODE-336	2027-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213793-001	ODE-402	2029-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	I-892	2025-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	NCE	2025-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	ODE-336	2027-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213793-001	ODE-402	2029-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	I-892	2025-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	NCE	2025-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213793-001	ODE-336	2027-11-25	`5bbf6a4d5a75…`

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
Imcivree	SETMELANOTIDE	Rhythm Pharmaceuticals, Inc	70c3ccf7-4df0-4c75-ba07-fede9970c8d9	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213793 application number: NDA213793 ndc (product): 72829-010

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
72829-010	Imcivree	setmelanotide	Rhythm Pharmaceuticals, Inc	NDA	Current
72829-010	Imcivree	setmelanotide	Rhythm Pharmaceuticals, Inc	NDA	Current
72829-010	Imcivree	setmelanotide	Rhythm Pharmaceuticals, Inc	NDA	Current
72829-010	Imcivree	setmelanotide	Rhythm Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85504	SUPPL	2026-03-24
85450	SUPPL	2026-03-23
83184	SUPPL	2025-08-25
83183	SUPPL	2025-08-25
80711	SUPPL	2025-01-15
80697	SUPPL	2024-12-23
76591	SUPPL	2023-11-16
76581	SUPPL	2023-11-16
71347	SUPPL	2022-06-17
71340	SUPPL	2022-06-16
65729	ORIG	2020-12-23
65422	ORIG	2020-11-30
65358	ORIG	2020-11-27