FDA.reportPublic FDA data

Application 205649

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;500MGYesNo
002XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GMYesNo
003XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;500MGYesNo
004XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;1GMYesYes
005XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2.5MG;1GMYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6225XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6250XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6260XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6270XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6280XIGDUOdapagliflozin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80707SUPPL 2024-12-26
80700SUPPL 2024-12-23
80699SUPPL 2024-12-23
78791SUPPL 2024-06-13
78790SUPPL 2024-06-13
75426SUPPL 2023-09-13
75413SUPPL 2023-09-13
72372SUPPL2022-10-17
72371SUPPL2022-10-17
72328SUPPL2022-10-14
70761SUPPL2022-04-14
70760SUPPL2022-04-14
70752SUPPL2022-04-12
70102SUPPL2022-02-07
70101SUPPL2022-02-07
70092SUPPL2022-02-04
61775SUPPL2020-02-04
61772SUPPL2020-02-04
61771SUPPL2020-02-04
61689SUPPL2020-01-27
61684SUPPL2020-01-27
61683SUPPL2020-01-27
61661SUPPL2020-01-27
60617SUPPL2019-10-22
60601SUPPL2019-10-21
60600SUPPL2019-10-21
57821SUPPL2019-02-27
57802SUPPL2019-02-25
56195SUPPL2018-10-30
56147SUPPL2018-10-29
52234SUPPL2018-02-01
47461SUPPL2017-03-03
47393SUPPL2017-03-02
45093SUPPL2016-08-22
45051SUPPL2016-08-17
40493SUPPL2016-06-17
32701SUPPL2016-06-16
40492SUPPL2015-12-08
32700SUPPL2015-12-07
43498ORIG2015-04-06
24500ORIG2015-04-06
40491ORIG2014-11-04
10486ORIG2014-10-31