Application 209210

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BYDUREON BCISE	EXENATIDE	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	2MG/0.85ML (2MG/0.85ML)	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
N209210-001	BYDUREON BCISE	EXENATIDE SYNTHETIC	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2017-10-20

Orange Book patents#

Current patent rows page 1 of 1 · 47 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209210-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2019-08-21
N209210-001	6515117*PED	2026-04-04		Pediatric extension
N209210-001	8329648	2026-08-18	U-2588		2017-11-03
N209210-001	8329648	2026-08-18	U-2589		2017-11-03
N209210-001	8329648	2026-08-18	U-2590		2017-11-03
N209210-001	8329648	2026-08-18	U-2593		2017-11-03
N209210-001	8329648	2026-08-18	U-2594		2017-11-03
N209210-001	8329648	2026-08-18	U-2595		2017-11-03
N209210-001	8329648	2026-08-18	U-2596		2017-11-03
N209210-001	8329648	2026-08-18	U-3188		2017-11-03
N209210-001	8329648	2026-08-18	U-3189		2017-11-03
N209210-001	8329648	2026-08-18	U-3190		2017-11-03
N209210-001	8906851	2026-08-18	U-2588		2017-11-03
N209210-001	8906851	2026-08-18	U-2589		2017-11-03
N209210-001	8906851	2026-08-18	U-2590		2017-11-03
N209210-001	8906851	2026-08-18	U-2593		2017-11-03
N209210-001	8906851	2026-08-18	U-2597		2017-11-03
N209210-001	8906851	2026-08-18	U-3188		2017-11-03
N209210-001	8906851	2026-08-18	U-3189		2017-11-03
N209210-001	8906851	2026-08-18	U-3190		2017-11-03
N209210-001	9884092	2026-08-18	U-2588		2018-03-06
N209210-001	9884092	2026-08-18	U-2589		2018-03-06
N209210-001	9884092	2026-08-18	U-2590		2018-03-06
N209210-001	9884092	2026-08-18	U-2593		2018-03-06
N209210-001	9884092	2026-08-18	U-2594		2018-03-06
N209210-001	9884092	2026-08-18	U-2595		2018-03-06
N209210-001	9884092	2026-08-18	U-2596		2018-03-06
N209210-001	9884092	2026-08-18	U-2597		2018-03-06
N209210-001	9884092	2026-08-18	U-3188		2018-03-06
N209210-001	9884092	2026-08-18	U-3189		2018-03-06
N209210-001	9884092	2026-08-18	U-3190		2018-03-06
N209210-001	8329648*PED	2027-02-18		Pediatric extension
N209210-001	8906851*PED	2027-02-18		Pediatric extension
N209210-001	9884092*PED	2027-02-18		Pediatric extension
N209210-001	8501698	2027-06-20	U-2588		2019-08-21
N209210-001	8501698*PED	2027-12-20		Pediatric extension
N209210-001	8361972	2028-03-21	U-2588		2019-08-21
N209210-001	8361972*PED	2028-09-21		Pediatric extension
N209210-001	8895033	2030-10-04	U-2589	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-2590	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-2597	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-2601	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-2602	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-3188	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-3189	Drug product	2017-11-03
N209210-001	8895033	2030-10-04	U-3190	Drug product	2017-11-03
N209210-001	8895033*PED	2031-04-04		Pediatric extension

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-10-20	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 82 · 3,255 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	N209210-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2590		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2593		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2594		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2596		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2595		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2588		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-2589		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-3189		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-3188		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648	2026-08-18	U-3190		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2590		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2593		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2597		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2589		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-3188		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-3189		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-2588		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851	2026-08-18	U-3190		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2593		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2589		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2594		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2596		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2597		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2595		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2590		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-2588		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-3188		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-3190		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092	2026-08-18	U-3189		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8329648*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8906851*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	9884092*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8501698	2027-06-20	U-2588		2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8361972	2028-03-21	U-2588		2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8361972*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8895033	2030-10-04	U-2597	Drug product	2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209210-001	8895033	2030-10-04	U-2590	Drug product	2017-11-03	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209210-001	NPP	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209210-001	PED	2025-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209210-001	NPP	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209210-001	PED	2025-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209210-001	NPP	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209210-001	PED	2025-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209210-001	NPP	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209210-001	PED	2025-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209210-001	NPP	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209210-001	PED	2025-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209210-001	NPP	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209210-001	PED	2025-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209210-001	NPP	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209210-001	PED	2025-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209210-001	NPP	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209210-001	PED	2025-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209210-001	NPP	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209210-001	PED	2025-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209210-001	NPP	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209210-001	PED	2025-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209210-001	NPP	2024-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209210-001	PED	2025-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209210-001	NPP	2024-07-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209210-001	PED	2025-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209210-001	NPP	2024-07-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209210-001	PED	2025-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	M-240	2022-02-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	PED	2023-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	NPP	2024-07-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209210-001	PED	2025-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209210-001	M-240	2022-02-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209210-001	PED	2023-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209210-001	NPP	2024-07-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209210-001	PED	2025-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209210-001	M-240	2022-02-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209210-001	PED	2023-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209210-001	NPP	2024-07-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209210-001	PED	2025-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209210-001	NP	2020-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209210-001	M-240	2022-02-15	`bb7c543d1eb4…`

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
Exenatide	EXENATIDE	Amneal Pharmaceuticals LLC	e6cb5c8f-e97f-4a6a-95a4-939fd2393949	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: EXENATIDE
Byetta	EXENATIDE	AstraZeneca Pharmaceuticals LP	53d03c03-ebf7-418d-88a8-533eabd2ee4f	2025-09-02	Warnings, Adverse reactions	Name fallback generic name: EXENATIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceutica	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6540	BYDUREON BCise	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82387	SUPPL	2025-06-02
82386	SUPPL	2025-06-02
82349	SUPPL	2025-05-29
80126	SUPPL	2024-11-05
80108	SUPPL	2024-11-04
80107	SUPPL	2024-11-04
77781	SUPPL	2024-03-12
77748	SUPPL	2024-03-07
73012	SUPPL	2022-12-23
73011	SUPPL	2022-12-23
72998	SUPPL	2022-12-22
71646	SUPPL	2022-07-27
71645	SUPPL	2022-07-27
71640	SUPPL	2022-07-27
71321	SUPPL	2022-06-15
71320	SUPPL	2022-06-15
71303	SUPPL	2022-06-14
68179	SUPPL	2021-07-26
68165	SUPPL	2021-07-23
65493	SUPPL	2020-12-03
65476	SUPPL	2020-12-02
65475	SUPPL	2020-12-02
62016	SUPPL	2020-03-03
62007	SUPPL	2020-03-02
62006	SUPPL	2020-03-02
59513	SUPPL	2019-07-30
59512	SUPPL	2019-07-30
59511	SUPPL	2019-07-30
59510	SUPPL	2019-07-30
59509	SUPPL	2019-07-30
59508	SUPPL	2019-07-30
59507	SUPPL	2019-07-30
59505	SUPPL	2019-07-30
59461	SUPPL	2019-07-26
59460	SUPPL	2019-07-26
59459	SUPPL	2019-07-26
59458	SUPPL	2019-07-26
59457	SUPPL	2019-07-26
59456	SUPPL	2019-07-26
59455	SUPPL	2019-07-26
57724	SUPPL	2019-02-21
57708	SUPPL	2019-02-20
55864	ORIG	2018-10-10
50488	ORIG	2017-11-27
50156	ORIG	2017-10-24