FDA.reportPublic FDA data

Application 210874

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QTERNMET XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2.5MG;1GM;EQ 2.5MG BASEYesNo
002QTERNMET XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GM;EQ 2.5MG BASEYesNo
003QTERNMET XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GM;EQ 5MG BASEYesNo
004QTERNMET XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;1GM;EQ 5MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-6925QTERNMETdapagliflozin saxagliptin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6950QTERNMETdapagliflozin saxagliptin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6975QTERNMETdapagliflozin saxagliptin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6990QTERNMETdapagliflozin saxagliptin and metformin hydrochlorideAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61691SUPPL2020-01-27
61687SUPPL2020-01-27
61685SUPPL2020-01-27
61651ORIG2020-01-27
59271SUPPL2019-07-08
59270SUPPL2019-07-08
59216SUPPL2019-07-02
58559ORIG2019-05-03
58538ORIG2019-05-03
58537ORIG2019-05-03