Application 022200

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BYDUREON	EXENATIDE SYNTHETIC	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	2MG/VIAL	Yes	Yes
002	BYDUREON PEN	EXENATIDE SYNTHETIC	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	2MG	Yes	Yes

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
N022200-001	BYDUREON	EXENATIDE SYNTHETIC	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2012-01-27
N022200-002	BYDUREON PEN	EXENATIDE SYNTHETIC	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2014-02-28

Orange Book patents#

Current patent rows page 1 of 1 · 72 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022200-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-17
N022200-001	6515117*PED	2026-04-04		Pediatric extension
N022200-001	8329648	2026-08-18	U-2588		2013-01-10
N022200-001	8329648	2026-08-18	U-2589		2013-01-10
N022200-001	8329648	2026-08-18	U-2590		2013-01-10
N022200-001	8329648	2026-08-18	U-2593		2013-01-10
N022200-001	8329648	2026-08-18	U-2594		2013-01-10
N022200-001	8329648	2026-08-18	U-2595		2013-01-10
N022200-001	8329648	2026-08-18	U-2596		2013-01-10
N022200-001	8329648	2026-08-18	U-3188		2013-01-10
N022200-001	8329648	2026-08-18	U-3189		2013-01-10
N022200-001	8329648	2026-08-18	U-3190		2013-01-10
N022200-001	8906851	2026-08-18	U-2588		2015-01-06
N022200-001	8906851	2026-08-18	U-2589		2015-01-06
N022200-001	8906851	2026-08-18	U-2590		2015-01-06
N022200-001	8906851	2026-08-18	U-2593		2015-01-06
N022200-001	8906851	2026-08-18	U-3188		2015-01-06
N022200-001	8906851	2026-08-18	U-3189		2015-01-06
N022200-001	8906851	2026-08-18	U-3190		2015-01-06
N022200-001	9884092	2026-08-18	U-2588		2018-03-06
N022200-001	9884092	2026-08-18	U-2589		2018-03-06
N022200-001	9884092	2026-08-18	U-2590		2018-03-06
N022200-001	9884092	2026-08-18	U-2593		2018-03-06
N022200-001	9884092	2026-08-18	U-2594		2018-03-06
N022200-001	9884092	2026-08-18	U-2595		2018-03-06
N022200-001	9884092	2026-08-18	U-2596		2018-03-06
N022200-001	9884092	2026-08-18	U-3188		2018-03-06
N022200-001	9884092	2026-08-18	U-3189		2018-03-06
N022200-001	9884092	2026-08-18	U-3190		2018-03-06
N022200-001	8329648*PED	2027-02-18		Pediatric extension
N022200-001	8906851*PED	2027-02-18		Pediatric extension
N022200-001	9884092*PED	2027-02-18		Pediatric extension
N022200-001	8501698	2027-06-20	U-2588	Drug product	2017-11-17
N022200-001	8501698*PED	2027-12-20		Pediatric extension
N022200-001	8361972	2028-03-21	U-2588		2017-11-17
N022200-001	8361972*PED	2028-09-21		Pediatric extension
N022200-002	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-15
N022200-002	6515117*PED	2026-04-04		Pediatric extension
N022200-002	8329648	2026-08-18	U-2588		2014-03-28
N022200-002	8329648	2026-08-18	U-2589		2014-03-28
N022200-002	8329648	2026-08-18	U-2590		2014-03-28
N022200-002	8329648	2026-08-18	U-2593		2014-03-28
N022200-002	8329648	2026-08-18	U-2594		2014-03-28
N022200-002	8329648	2026-08-18	U-2595		2014-03-28
N022200-002	8329648	2026-08-18	U-2596		2014-03-28
N022200-002	8329648	2026-08-18	U-3188		2014-03-28
N022200-002	8329648	2026-08-18	U-3189		2014-03-28
N022200-002	8329648	2026-08-18	U-3190		2014-03-28
N022200-002	8906851	2026-08-18	U-2588		2015-01-06
N022200-002	8906851	2026-08-18	U-2589		2015-01-06
N022200-002	8906851	2026-08-18	U-2590		2015-01-06
N022200-002	8906851	2026-08-18	U-2593		2015-01-06
N022200-002	8906851	2026-08-18	U-3188		2015-01-06
N022200-002	8906851	2026-08-18	U-3189		2015-01-06
N022200-002	8906851	2026-08-18	U-3190		2015-01-06
N022200-002	9884092	2026-08-18	U-2588		2018-03-06
N022200-002	9884092	2026-08-18	U-2589		2018-03-06
N022200-002	9884092	2026-08-18	U-2590		2018-03-06
N022200-002	9884092	2026-08-18	U-2593		2018-03-06
N022200-002	9884092	2026-08-18	U-2594		2018-03-06
N022200-002	9884092	2026-08-18	U-2595		2018-03-06
N022200-002	9884092	2026-08-18	U-2596		2018-03-06
N022200-002	9884092	2026-08-18	U-3188		2018-03-06
N022200-002	9884092	2026-08-18	U-3189		2018-03-06
N022200-002	9884092	2026-08-18	U-3190		2018-03-06
N022200-002	8329648*PED	2027-02-18		Pediatric extension
N022200-002	8906851*PED	2027-02-18		Pediatric extension
N022200-002	9884092*PED	2027-02-18		Pediatric extension
N022200-002	8501698	2027-06-20	U-2588	Drug product	2017-11-15
N022200-002	8501698*PED	2027-12-20		Pediatric extension
N022200-002	8361972	2028-03-21	U-2588		2017-11-15
N022200-002	8361972*PED	2028-09-21		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	N022200-001	BYDUREON	2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2012-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	BYDUREON PEN	2MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2014-02-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 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	N022200-001	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2590		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2589		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2595		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2593		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2596		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2588		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-2594		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-3188		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-3189		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648	2026-08-18	U-3190		2013-01-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-2593		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-2589		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-2588		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-2590		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-3190		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-3189		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851	2026-08-18	U-3188		2015-01-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2593		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2594		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2595		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2596		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2590		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2588		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-2589		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-3190		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-3189		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092	2026-08-18	U-3188		2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8329648*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8906851*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	9884092*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8501698	2027-06-20	U-2588	Drug product	2017-11-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8361972	2028-03-21	U-2588		2017-11-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-001	8361972*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	6515117	2025-10-04	U-2588	Drug substance, Drug product	2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	8329648	2026-08-18	U-2596		2014-03-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022200-002	8329648	2026-08-18	U-2595		2014-03-28	`a50c72e98297…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-6520	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6520	BYDUREON	exenatide	AstraZeneca Pharmaceutica	NDA	Current
0310-6520	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6520	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceutica	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6530	BYDUREON	exenatide	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82384	SUPPL	2025-06-02
82383	SUPPL	2025-06-02
82343	SUPPL	2025-05-29
80119	SUPPL	2024-11-05
80105	SUPPL	2024-11-04
73014	SUPPL	2022-12-23
73013	SUPPL	2022-12-23
72993	SUPPL	2022-12-22
71642	SUPPL	2022-07-27
71641	SUPPL	2022-07-27
71637	SUPPL	2022-07-27
71323	SUPPL	2022-06-15
71322	SUPPL	2022-06-15
71281	SUPPL	2022-06-13
68178	SUPPL	2021-07-26
68166	SUPPL	2021-07-22
62013	SUPPL	2020-03-03
62003	SUPPL	2020-03-02
57725	SUPPL	2019-02-21
57712	SUPPL	2019-02-20
56237	SUPPL	2018-11-01
53592	SUPPL	2018-04-03
53591	SUPPL	2018-04-03
50154	SUPPL	2017-10-24
50143	SUPPL	2017-10-23
38373	SUPPL	2015-10-07
38372	SUPPL	2015-10-07
17074	SUPPL	2015-10-07
38371	SUPPL	2015-10-06
29395	SUPPL	2015-09-28
7035	SUPPL	2015-09-28
7034	SUPPL	2015-09-28
7033	SUPPL	2015-09-28
38374	SUPPL	2015-09-23
7037	SUPPL	2015-09-22
7031	SUPPL	2015-05-05
17075	SUPPL	2015-03-27
7036	SUPPL	2015-03-11
17073	SUPPL	2015-03-09
29394	SUPPL	2015-03-06
42446	SUPPL	2014-08-05
38370	SUPPL	2014-05-28
17072	SUPPL	2014-05-28
29393	SUPPL	2014-05-27
7032	SUPPL	2014-05-27
7030	SUPPL	2014-03-05
17071	SUPPL	2014-03-04
44698	ORIG	2012-06-12
42445	ORIG	2012-06-12
17070	ORIG	2012-01-27
7029	ORIG	2012-01-27