Application 022225

Type: NDA
Sponsor: ORGANON SUB MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRIDION	SUGAMMADEX SODIUM	SOLUTION;INTRAVENOUS	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	Yes	Yes
002	BRIDION	SUGAMMADEX SODIUM	SOLUTION;INTRAVENOUS	EQ 200MG BASE/2ML (EQ 100MG BASE/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022225-001	BRIDION	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15
N022225-002	BRIDION	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022225-001	AP
N022225-002	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12
N022225-001	RE44733*PED	2026-07-27		Pediatric extension
N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12
N022225-002	RE44733*PED	2026-07-27		Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022225-001	NPP	2027-12-12
N022225-001	PED	2028-06-12
N022225-002	NPP	2027-12-12
N022225-002	PED	2028-06-12

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2015-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2015-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2015-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2015-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-12-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2015-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022225-001	BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-12-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022225-002	BRIDION	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2015-12-15	`782e0a99824c…`

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
2026-02-19 14:30 UTC	2026-02	N022225-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022225-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022225-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022225-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022225-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022225-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022225-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022225-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022225-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022225-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022225-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022225-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022225-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022225-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022225-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022225-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022225-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022225-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022225-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022225-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022225-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022225-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022225-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022225-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022225-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022225-002	AP	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 128 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	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022225-001	RE44733*PED	2026-07-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022225-002	RE44733*PED	2026-07-27		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-001	RE44733*PED	2026-07-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-002	RE44733*PED	2026-07-27		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022225-001	RE44733*PED	2026-07-27		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022225-002	RE44733*PED	2026-07-27		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-001	RE44733*PED	2026-07-27		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-002	RE44733*PED	2026-07-27		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-001	RE44733*PED	2026-07-27		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-002	RE44733*PED	2026-07-27		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-001	RE44733*PED	2026-07-27		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-002	RE44733*PED	2026-07-27		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-001	RE44733*PED	2026-07-27		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-002	RE44733*PED	2026-07-27		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022225-001	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022225-002	RE44733	2026-01-27	U-1794	Drug substance, Drug product	2016-01-12	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 162 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	N022225-001	NPP	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022225-001	PED	2028-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022225-002	NPP	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022225-002	PED	2028-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-001	NPP	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-001	PED	2028-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-002	NPP	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022225-002	PED	2028-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022225-001	NPP	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022225-001	PED	2028-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022225-002	NPP	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022225-002	PED	2028-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-001	NPP	2027-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-001	PED	2028-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-002	NPP	2027-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022225-002	PED	2028-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-001	NPP	2027-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-001	PED	2028-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-002	NPP	2027-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022225-002	PED	2028-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-001	M-291	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-001	NPP	2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-002	M-291	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022225-002	NPP	2024-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-001	M-291	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-001	NPP	2024-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-002	M-291	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022225-002	NPP	2024-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-001	M-291	2024-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-001	NPP	2024-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-002	M-291	2024-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022225-002	NPP	2024-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-001	M-291	2024-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-001	NPP	2024-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-002	M-291	2024-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022225-002	NPP	2024-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022225-001	M-291	2024-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022225-001	NPP	2024-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022225-002	M-291	2024-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022225-002	NPP	2024-06-25	`d06236e962d9…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRIDION	SUGAMMADEX	Merck Sharp & Dohme LLC	5171d883-fe8f-482c-97ab-40b00975b64a	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022225 application number: NDA022225 ndc (product): 0006-5423 ndc (product): 0006-5425
BRIDION	SUGAMMADEX	ProPharma Distribution	37276948-ff0f-e0ab-e063-6394a90a0973	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022225 application number: NDA022225
BRIDION	SUGAMMADEX	Medical Purchasing Solutions, LLC	9e3eb206-5c35-2c93-e053-2a95a90a9df0	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022225 application number: NDA022225 ndc (product): 71872-7187

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-5423	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5423	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5423	BRIDION	sugammadex	Merck Sharp & Dohme LLC	NDA	Current
0006-5423	BRIDION	sugammadex	Merck Sharp & Dohme LLC	NDA	Current
0006-5423	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5423	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5423	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5425	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5425	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5425	BRIDION	sugammadex	Merck Sharp & Dohme LLC	NDA	Current
0006-5425	BRIDION	sugammadex	Merck Sharp & Dohme LLC	NDA	Current
0006-5425	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5425	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
0006-5425	BRIDION	sugammadex	Merck Sharp & Dohme Corp.	NDA	Current
71872-7187	BRIDION	sugammadex	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80584	SUPPL	2024-12-16
80565	SUPPL	2024-12-13
72649	SUPPL	2022-11-18
72658	SUPPL	2022-11-17
68010	SUPPL	2021-07-02
67941	SUPPL	2021-06-29
66005	SUPPL	2021-01-27
66004	SUPPL	2021-01-27
65986	SUPPL	2021-01-26
65985	SUPPL	2021-01-26
63514	SUPPL	2020-06-12
63473	SUPPL	2020-06-10
61088	SUPPL	2019-11-29
45652	SUPPL	2016-10-26
24263	ORIG	2016-02-04
21964	ORIG	2016-02-04
29429	ORIG	2015-12-16
17105	ORIG	2015-12-16