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ACTIVE SUBSTANCE / INN

DAPAGLIFLOZIN

Brand name(s): DAPAGLIFLOZIN AND SAXAGLIPTIN, DAPAGLIFLOZIN, Dapagliflozin Viatris, QTERNMET XR, QTERN, DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE, Edistride, Forxiga, XIGDUO XR, FARXIGA
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA211439
ANDA211583
ACTIVE SUBSTANCE
Dapagliflozin
REGULATORS
FDA · EMA
SPONSORS / MAH
AstraZeneca AB, MSN LABS PVT LTD, ASTRAZENECA AB
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
QTERNMET XRNDA210874ASTRAZENECA ABDiscontinued
DAPAGLIFLOZINANDA211439HETERO LABS UNIT IIINone (Tentative Approval)
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDEANDA211583TEVA PHARMS USA INCNone (Tentative Approval)
QTERNNDA209091ASTRAZENECA ABDiscontinued
XIGDUO XRNDA205649ASTRAZENECA ABPrescription
FARXIGANDA202293ASTRAZENECA ABPrescription
DAPAGLIFLOZIN AND SAXAGLIPTINANDA211533MSN LABS PVT LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
EdistrideAstraZeneca ABAuthorised09/11/2015Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficie…
ForxigaAstraZeneca ABAuthorised11/11/2012Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficie…
Dapagliflozin ViatrisViatris LimitedAuthorised24/03/2023Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficie…

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