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FDA NDA · NDA200678

KOMBIGLYZE XR

Sponsor: ASTRAZENECA AB

APPLICATION
NDA200678
TYPE
NDA
ORIGINAL APPROVAL
2010-11-05
LATEST ACTION
2024-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

KOMBIGLYZE XR · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM, SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
KOMBIGLYZE XR · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM, SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
KOMBIGLYZE XR · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG, SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-10-11Efficacy · Supplement 28 · standard — Label ↗AP
2019-07-01Labeling · Supplement 24 · 901 required — Letter ↗AP
2017-02-27Efficacy · Supplement 18 · standard — Label ↗AP
2017-01-18Labeling · Supplement 20 · standard — Label ↗AP
2017-01-18Labeling · Supplement 19 · 901 required — Label ↗AP
2016-04-05Efficacy · Supplement 13 · standard — Label ↗AP
2015-08-28Labeling · Supplement 16 · 901 required — Letter ↗AP
2015-02-09Manufacturing (CMC) · Supplement 14 · standardAP
2013-05-24Efficacy · Supplement 10 · standard — Label ↗AP
2013-05-15Manufacturing (CMC) · Supplement 2 · standardAP
2012-11-08Manufacturing (CMC) · Supplement 9 · standardAP
2012-04-01Labeling · Supplement 7 · unknown — Letter ↗AP
2012-03-07Efficacy · Supplement 4 · standard — Label ↗AP
2012-03-07Efficacy · Supplement 3 · standard — Label ↗AP
2011-11-15Labeling · Supplement 5 · unknown — Label ↗AP
2010-11-05Type 4 - New Combination · Original · standard — Summary Review ↗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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