Application 210557

Type: NDA
Sponsor: AMAG PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VYLEESI (AUTOINJECTOR)	BREMELANOTIDE ACETATE	SOLUTION;SUBCUTANEOUS	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N210557-001	VYLEESI (AUTOINJECTOR)	BREMELANOTIDE ACETATE	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2019-06-21

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N210557-001	10286034	2033-11-05	U-2568	2019-07-10
N210557-001	9352013	2033-11-05	U-2568	2019-07-10
N210557-001	9700592	2033-11-05	U-2568	2019-07-10
N210557-001	11590209	2041-04-29	U-3539	2023-03-10

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N210557-001	VYLEESI (AUTOINJECTOR)	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210557-001	VYLEESI (AUTOINJECTOR)	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210557-001	VYLEESI (AUTOINJECTOR)	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-06-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210557-001	VYLEESI (AUTOINJECTOR)	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-06-21	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 206 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210557-001	11590209	2041-04-29	U-3539		2023-03-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210557-001	11590209	2041-04-29	U-3539		2023-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210557-001	11590209	2041-04-29	U-3539		2023-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210557-001	11590209	2041-04-29	U-3539		2023-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210557-001	6794489	2025-06-28		Drug substance, Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210557-001	11590209	2041-04-29	U-3539		2023-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210557-001	6794489	2025-06-28		Drug substance, Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210557-001	11590209	2041-04-29	U-3539		2023-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210557-001	6794489	2025-06-28		Drug substance, Drug product	2019-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210557-001	11590209	2041-04-29	U-3539		2023-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210557-001	6794489	2025-06-28		Drug substance, Drug product	2019-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210557-001	11590209	2041-04-29	U-3539		2023-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210557-001	6794489	2025-06-28		Drug substance, Drug product	2019-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210557-001	10286034	2033-11-05	U-2568		2019-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210557-001	9352013	2033-11-05	U-2568		2019-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210557-001	9700592	2033-11-05	U-2568		2019-07-10	`03ed91905a0d…`

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	N210557-001	NCE	2024-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210557-001	NCE	2024-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210557-001	NCE	2024-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210557-001	NCE	2024-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210557-001	NCE	2024-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210557-001	NCE	2024-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210557-001	NCE	2024-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210557-001	NCE	2024-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210557-001	NCE	2024-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210557-001	NCE	2024-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210557-001	NCE	2024-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210557-001	NCE	2024-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210557-001	NCE	2024-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210557-001	NCE	2024-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210557-001	NCE	2024-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210557-001	NCE	2024-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210557-001	NCE	2024-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210557-001	NCE	2024-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210557-001	NCE	2024-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210557-001	NCE	2024-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210557-001	NCE	2024-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210557-001	NCE	2024-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210557-001	NCE	2024-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210557-001	NCE	2024-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210557-001	NCE	2024-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210557-001	NCE	2024-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210557-001	NCE	2024-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210557-001	NCE	2024-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210557-001	NCE	2024-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210557-001	NCE	2024-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210557-001	NCE	2024-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210557-001	NCE	2024-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210557-001	NCE	2024-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210557-001	NCE	2024-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210557-001	NCE	2024-06-21	`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
Vyleesi	BREMELANOTIDE	Cosette Pharmaceuticals, Inc.	f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210557 application number: NDA210557

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64011-701	Vyleesi	bremelanotide	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-701	Vyleesi	bremelanotide	AMAG Pharmaceuticals, Inc.	NDA	Current
64011-701	Vyleesi	bremelanotide	AMAG Pharmaceuticals, Inc.	NDA	Current
80064-141	Vyleesi	bremelanotide	Palatin Technologies	NDA	Current
80064-141	Vyleesi	bremelanotide	Palatin Technologies	NDA	Current
80064-141	Vyleesi	bremelanotide	Palatin Technologies	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65041	SUPPL	2020-10-27
65030	SUPPL	2020-10-27
59579	ORIG	2019-08-06
59164	ORIG	2019-08-02
59159	ORIG	2019-06-21