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 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
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.

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
2026-08-01 22:54:32	2026-06	N209210-001	BYDUREON BCISE	2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2017-10-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N209210-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2019-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2590		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2593		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2594		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2596		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2595		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2588		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-2589		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-3189		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-3188		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648	2026-08-18	U-3190		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2590		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2593		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2597		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2589		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-3188		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-3189		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-2588		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851	2026-08-18	U-3190		2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2593		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2589		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2594		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2596		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2597		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2595		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2590		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-2588		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-3188		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-3190		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092	2026-08-18	U-3189		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8329648*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8906851*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	9884092*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8501698	2027-06-20	U-2588		2019-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8361972	2028-03-21	U-2588		2019-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8361972*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8895033	2030-10-04	U-2597	Drug product	2017-11-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209210-001	8895033	2030-10-04	U-2590	Drug product	2017-11-03	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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