← FDA DRUG APPROVALS

FDA NDA · NDA202270

JANUMET XR

sitagliptin and metformin hydrochloride

Sponsor: MSD SUB MERCK

APPLICATION
NDA202270
TYPE
NDA
ORIGINAL APPROVAL
2012-02-02
LATEST ACTION
2022-06-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

JANUMET XR · ReferencePrescription
METFORMIN HYDROCHLORIDE 1GM, SITAGLIPTIN PHOSPHATE EQ 100MG BASE · TABLET, EXTENDED RELEASE · ORAL
JANUMET XR · ReferencePrescription
METFORMIN HYDROCHLORIDE 500MG, SITAGLIPTIN PHOSPHATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL
JANUMET XR · ReferencePrescription
METFORMIN HYDROCHLORIDE 1GM, SITAGLIPTIN PHOSPHATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-06-21Labeling · Supplement 26 · standard — Letter ↗AP
2021-11-04Labeling · Supplement 25 · standard — Letter ↗AP
2020-12-04Efficacy · Supplement 22 · priority — Label ↗AP
2019-08-12Efficacy · Supplement 19 · standard — Letter ↗AP
2019-07-01Labeling · Supplement 20 · 901 required — Letter ↗AP
2018-02-09Labeling · Supplement 18 · standard — Label ↗AP
2017-08-10Labeling · Supplement 17 · standard — Label ↗AP
2017-01-18Labeling · Supplement 15 · 901 required — Label ↗AP
2017-01-18Labeling · Supplement 16 · standard — Label ↗AP
2015-08-28Labeling · Supplement 10 · 901 required — Label ↗AP
2015-04-27Labeling · Supplement 9 · standard — Label ↗AP
2014-09-19Manufacturing (CMC) · Supplement 8 · standardAP
2014-02-12Labeling · Supplement 6 · standard — Label ↗AP
2013-10-17Manufacturing (CMC) · Supplement 5 · standardAP
2013-07-19Manufacturing (CMC) · Supplement 4 · standardAP
2013-04-10Manufacturing (CMC) · Supplement 1 · standardAP
2013-02-11Labeling · Supplement 3 · standard — Label ↗AP
2012-10-18Labeling · Supplement 2 · unknown — Letter ↗AP
2012-02-02Type 3 - New Dosage Form · Original · standard — Review ↗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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