dapagliflozin Oral Tablet

Brand(s)
Farxiga
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-03-12)
Oldest Current Product
2014-01-08
License(s)
NDA
RxNORM
ORAL TABLET\DAPAGLIFLOZIN
FDAOB
ORAL\TABLET\DAPAGLIFLOZIN PROPANEDIOL
SPL Active
ORAL\TABLET, FILM COATED\DAPAGLIFLOZIN PROPANEDIOL
SPL Moiety
ORAL\TABLET, FILM COATED\DAPAGLIFLOZIN

product(s) by strength(s)

dapagliflozin 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000031428FarxigaNDAE.R. Squibb & Sons, L.L.C.2014-01-082017-08-31DAPAGLIFLOZIN PROPANEDIOLORALTABLET, FILM COATEDNDA202293fc6ae30e-868b-4ac9-b69d-900922503998

dapagliflozin 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106205FarxigaNDAAstrazeneca Pharmaceuticals Lp2015-01-05DAPAGLIFLOZIN PROPANEDIOLORALTABLET, FILM COATEDNDA20229372ad22ae-efe6-4cd6-a302-98aaee423d69

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202293FARXIGAASTRAZENECA AB2014-01-08p6414126, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
p8501698, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
p8361972, TREATMENT OF TYPE 2 DIABETES MELLITUS
p7919598
p7851502, SUBSTANCE
p8685934, TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT
p6515117, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
p6936590, TREATMENT OF TYPE 2 DIABETES MELLITUS
p8716251, SUBSTANCE
p8221786, SUBSTANCE
INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLITFLOZIN 10MG ONCE DAILY IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND SULFONYLUREA [2018-03-11]
NEW CHEMICAL ENTITY [2019-01-08]
NDA202293_001, NDA202293_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202293_001RXDAPAGLIFLOZIN PROPANEDIOL (EQ 5MG BASE)ORALTABLETFalse2014-01-08FARXIGA
2NDA202293_002RXDAPAGLIFLOZIN PROPANEDIOL (EQ 10MG BASE)ORALTABLETTrue2014-01-08FARXIGA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6414126 (view patent)2020-10-04NDA202293, NDA205649dapagliflozin / Metformin Extended Release Oral Tablet
2p6515117 (view patent)2020-10-04NDA202293, NDA205649dapagliflozin / Metformin Extended Release Oral Tablet
3p6936590 (view patent)2020-10-04NDA202293, NDA205649dapagliflozin / Metformin Extended Release Oral Tablet
4p7851502 (view patent)2028-08-19NDA202293
5p7919598 (view patent)2029-12-16NDA202293, NDA205649dapagliflozin / Metformin Extended Release Oral Tablet
6p8221786 (view patent)2028-03-21NDA202293
7p8361972 (view patent)2028-03-21NDA202293
8p8501698 (view patent)2027-06-20NDA202293, NDA205649dapagliflozin / Metformin Extended Release Oral Tablet
9p8685934 (view patent)2030-05-26NDA202293, NDA205649dapagliflozin / Metformin Extended Release Oral Tablet
10p8716251 (view patent)2028-03-21NDA202293

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
172ad22ae-efe6-4cd6-a302-98aaee423d69 (view SPL)These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA (dapagliflozin) tablets, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-03-123003106205, 003106210
2fc6ae30e-868b-4ac9-b69d-900922503998 (view SPL)These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA (dapagliflozin) tablets, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2014-08-113000031428, 000031427

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII