FDA.reportPublic FDA data

Application 022200

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BYDUREONEXENATIDE SYNTHETICFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS2MG/VIALYesYes
002BYDUREON PENEXENATIDE SYNTHETICFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS2MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-6520BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6520BYDUREONexenatideAstraZeneca PharmaceuticaNDACurrent
0310-6520BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6520BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca PharmaceuticaNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6530BYDUREONexenatideAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82384SUPPL 2025-06-02
82383SUPPL 2025-06-02
82343SUPPL 2025-05-29
80119SUPPL 2024-11-05
80105SUPPL 2024-11-04
73014SUPPL2022-12-23
73013SUPPL2022-12-23
72993SUPPL2022-12-22
71642SUPPL2022-07-27
71641SUPPL2022-07-27
71637SUPPL2022-07-27
71323SUPPL2022-06-15
71322SUPPL2022-06-15
71281SUPPL2022-06-13
68178SUPPL2021-07-26
68166SUPPL2021-07-22
62013SUPPL2020-03-03
62003SUPPL2020-03-02
57725SUPPL2019-02-21
57712SUPPL2019-02-20
56237SUPPL2018-11-01
53592SUPPL2018-04-03
53591SUPPL2018-04-03
50154SUPPL2017-10-24
50143SUPPL2017-10-23
38373SUPPL2015-10-07
38372SUPPL2015-10-07
17074SUPPL2015-10-07
38371SUPPL2015-10-06
29395SUPPL2015-09-28
7035SUPPL2015-09-28
7034SUPPL2015-09-28
7033SUPPL2015-09-28
38374SUPPL2015-09-23
7037SUPPL2015-09-22
7031SUPPL2015-05-05
17075SUPPL2015-03-27
7036SUPPL2015-03-11
17073SUPPL2015-03-09
29394SUPPL2015-03-06
42446SUPPL2014-08-05
38370SUPPL2014-05-28
17072SUPPL2014-05-28
29393SUPPL2014-05-27
7032SUPPL2014-05-27
7030SUPPL2014-03-05
17071SUPPL2014-03-04
44698ORIG2012-06-12
42445ORIG2012-06-12
17070ORIG2012-01-27
7029ORIG2012-01-27