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FDA NDA · NDA209091

QTERN

Sponsor: ASTRAZENECA AB

APPLICATION
NDA209091
TYPE
NDA
ORIGINAL APPROVAL
2017-02-27
LATEST ACTION
2026-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

QTERN · ReferenceDiscontinued
DAPAGLIFLOZIN 5MG, SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
QTERN · ReferenceDiscontinued
DAPAGLIFLOZIN 10MG, SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2026-06-03Labeling · Supplement 9 · standard — Letter ↗AP
2023-09-12Labeling · Supplement 8 · standard — Letter ↗AP
2022-10-13Labeling · Supplement 7 · 901 required — Letter ↗AP
2022-03-04Labeling · Supplement 6 · standard — Letter ↗AP
2020-01-24Labeling · Supplement 5 · 901 required — Label ↗AP
2019-07-01Labeling · Supplement 4 · 901 required — Letter ↗AP
2019-05-02Efficacy · Supplement 2 · standard — Label ↗AP
2018-10-26Labeling · Supplement 3 · standard — Letter ↗AP
2017-02-27Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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