dapagliflozin / Metformin Extended Release Oral Tablet

Brand(s)
Xigduo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2014-10-30)
Oldest Current Product
2014-11-14
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\DAPAGLIFLOZIN:METFORMIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\DAPAGLIFLOZIN PROPANEDIOL: METFORMIN HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\DAPAGLIFLOZIN PROPANEDIOL: METFORMIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\DAPAGLIFLOZIN: METFORMIN

product(s) by strength(s)

24 hr dapagliflozin 10 mg / metformin hydrochloride 1000 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106280XigduoNDAAstrazeneca Pharmaceuticals Lp2014-11-14DAPAGLIFLOZIN PROPANEDIOL, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA205649ac8a0f7b-9f69-4495-abbc-3a47cd75a859

24 hr dapagliflozin 10 mg / metformin hydrochloride 500 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106270XigduoNDAAstrazeneca Pharmaceuticals Lp2014-11-14DAPAGLIFLOZIN PROPANEDIOL, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA205649ac8a0f7b-9f69-4495-abbc-3a47cd75a859

24 hr dapagliflozin 5 mg / metformin hydrochloride 1000 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106260XigduoNDAAstrazeneca Pharmaceuticals Lp2014-11-14DAPAGLIFLOZIN PROPANEDIOL, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA205649ac8a0f7b-9f69-4495-abbc-3a47cd75a859

24 hr dapagliflozin 5 mg / metformin hydrochloride 500 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106250XigduoNDAAstrazeneca Pharmaceuticals Lp2014-11-14DAPAGLIFLOZIN PROPANEDIOL, METFORMIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA205649ac8a0f7b-9f69-4495-abbc-3a47cd75a859

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205649XIGDUO XRASTRAZENECA AB2014-10-29p6414126, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
p8501698, TREATMENT OF TYPE 2 DIABETES MELLITUS, SUBSTANCE
p7919598
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
NEW CHEMICAL ENTITY [2019-01-08]NDA205649_001, NDA205649_002, NDA205649_003, NDA205649_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205649_001RXMETFORMIN HYDROCHLORIDE (500MG), DAPAGLIFLOZIN PROPANEDIOL (EQ 5MG BASE)ORALTABLET, EXTENDED RELEASEFalse2014-10-29XIGDUO XR
2NDA205649_002RXDAPAGLIFLOZIN PROPANEDIOL (EQ 5MG BASE), METFORMIN HYDROCHLORIDE (1GM)ORALTABLET, EXTENDED RELEASEFalse2014-10-29XIGDUO XR
3NDA205649_003RXMETFORMIN HYDROCHLORIDE (500MG), DAPAGLIFLOZIN PROPANEDIOL (EQ 10MG BASE)ORALTABLET, EXTENDED RELEASEFalse2014-10-29XIGDUO XR
4NDA205649_004RXDAPAGLIFLOZIN PROPANEDIOL (EQ 10MG BASE), METFORMIN HYDROCHLORIDE (1GM)ORALTABLET, EXTENDED RELEASETrue2014-10-29XIGDUO XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6414126 (view patent)2020-10-04NDA205649, NDA202293dapagliflozin Oral Tablet
2p6515117 (view patent)2020-10-04NDA205649, NDA202293dapagliflozin Oral Tablet
3p6936590 (view patent)2020-10-04NDA205649, NDA202293dapagliflozin Oral Tablet
4p7919598 (view patent)2029-12-16NDA205649, NDA202293dapagliflozin Oral Tablet
5p8501698 (view patent)2027-06-20NDA205649, NDA202293dapagliflozin Oral Tablet
6p8685934 (view patent)2030-05-26NDA205649, NDA202293dapagliflozin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1ac8a0f7b-9f69-4495-abbc-3a47cd75a859 (view SPL)These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full prescribing information for XIGDUO XR.XIGDUO XR (dapagliflozin and metformin HCl extended-release) tablets, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2014-10-301003106250, 003106260, 003106270, 003106280

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