← FDA DRUG APPROVALS

FDA NDA · NDA210874

QTERNMET XR

Sponsor: ASTRAZENECA AB

APPLICATION
NDA210874
TYPE
NDA
ORIGINAL APPROVAL
2019-05-02
LATEST ACTION
2020-01-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

QTERNMET XR · ReferenceDiscontinued
DAPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 1GM, SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE · TABLET, EXTENDED RELEASE · ORAL
QTERNMET XR · ReferenceDiscontinued
DAPAGLIFLOZIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM, SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
QTERNMET XR · ReferenceDiscontinued
DAPAGLIFLOZIN 10MG, METFORMIN HYDROCHLORIDE 1GM, SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE · TABLET, EXTENDED RELEASE · ORAL
QTERNMET XR · ReferenceDiscontinued
DAPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 1GM, SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2020-01-24Labeling · Supplement 3 · 901 required — Label ↗AP
2019-07-01Labeling · Supplement 1 · 901 required — Letter ↗AP
2019-05-02Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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