← FDA DRUG APPROVALS

FDA NDA · NDA205649

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Sponsor: ASTRAZENECA AB

APPLICATION
NDA205649
TYPE
NDA
ORIGINAL APPROVAL
2014-10-29
LATEST ACTION
2024-12-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

XIGDUO XR · ReferencePrescription
DAPAGLIFLOZIN 10MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
XIGDUO XR · ReferencePrescription
DAPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
XIGDUO XR · ReferencePrescription
DAPAGLIFLOZIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
XIGDUO XR · ReferencePrescription
DAPAGLIFLOZIN 10MG, METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
XIGDUO XR · ReferencePrescription
DAPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-12-20Efficacy · Supplement 23 · standard — Label ↗AP
2024-06-12Efficacy · Supplement 22 · priority — Letter ↗AP
2023-09-12Labeling · Supplement 21 · standard — Letter ↗AP
2022-10-13Labeling · Supplement 18 · 901 required — Letter ↗AP
2022-04-11Efficacy · Supplement 17 · standard — Letter ↗AP
2022-02-03Efficacy · Supplement 16 · standard — Letter ↗AP
2020-02-03Labeling · Supplement 14 · standard — Label ↗AP
2020-01-24Labeling · Supplement 13 · 901 required — Label ↗AP
2019-10-18Efficacy · Supplement 11 · standard — Label ↗AP
2019-08-12Manufacturing (CMC) · Supplement 12 — Letter ↗TA
2019-02-22Efficacy · Supplement 9 · standard — Label ↗AP
2018-10-26Labeling · Supplement 10 · standard — Letter ↗AP
2017-07-28Manufacturing (CMC) · Supplement 8 — Label ↗AP
2017-03-01Labeling · Supplement 6 · standard — Label ↗AP
2017-01-10Manufacturing (CMC) · Supplement 7 · standardAP
2016-08-17Labeling · Supplement 5 · standard — Letter ↗AP
2016-06-14Labeling · Supplement 4 · standard — Label ↗AP
2016-01-12Manufacturing (CMC) · Supplement 2 · standardAP
2015-12-04Labeling · Supplement 3 · 901 required — Label ↗AP
2015-09-01Manufacturing (CMC) · Supplement 1 · standardAP
2014-10-29Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →