FDA.reportPublic FDA data

Application 202293

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FARXIGADAPAGLIFLOZINTABLET;ORAL5MGYesNo
002FARXIGADAPAGLIFLOZINTABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6205FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6210FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LPNDACurrent
50090-3481FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3481FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3481FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3481FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3481FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3481FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3482FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3482FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3482FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
50090-3482FARXIGADAPAGLIFLOZINA-S Medication SolutionsNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal Health 107, LLCNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal Health 107, LLCNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal Health 107, LLCNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6932FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal Health 107, LLCNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal HealthNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal Health 107, LLCNDACurrent
55154-6933FARXIGADAPAGLIFLOZINCardinal Health 107, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78794SUPPL 2024-06-13
78793SUPPL 2024-06-13
78789SUPPL 2024-06-13
75424SUPPL 2023-09-13
75412SUPPL 2023-09-13
74969SUPPL 2023-08-01
74198SUPPL 2023-05-09
74194SUPPL 2023-05-09
73119SUPPL2023-01-09
73118SUPPL2023-01-09
73098SUPPL2023-01-05
72370SUPPL2022-10-17
72369SUPPL2022-10-17
72327SUPPL2022-10-14
69650SUPPL2021-12-20
68890SUPPL2021-10-05
68761SUPPL2021-09-24
67391SUPPL2021-05-04
67322SUPPL2021-05-03
67321SUPPL2021-05-03
62832SUPPL2020-05-06
62829SUPPL2020-05-06
62828SUPPL2020-05-06
61769SUPPL2020-04-10
61774SUPPL2020-02-04
61770SUPPL2020-02-04
61688SUPPL2020-01-27
61680SUPPL2020-01-27
61679SUPPL2020-01-27
60616SUPPL2019-10-22
60603SUPPL2019-10-21
60602SUPPL2019-10-21
57820SUPPL2019-02-27
57800SUPPL2019-02-25
56193SUPPL2018-10-30
56146SUPPL2018-10-29
50159SUPPL2017-10-24
50134SUPPL2017-10-23
47460SUPPL2017-03-03
47395SUPPL2017-03-02
45091SUPPL2016-08-22
45049SUPPL2016-08-17
40164SUPPL2016-06-17
10018SUPPL2016-06-16
40163SUPPL2015-12-08
32229SUPPL2015-12-08
19314SUPPL2015-03-17
10016SUPPL2015-03-12
19315SUPPL2014-08-12
10017SUPPL2014-08-11
68891ORIG2014-02-11
24414ORIG2014-02-11
22884ORIG2014-02-11
40162ORIG2014-01-10
10015ORIG2014-01-10