JANUMET · ReferencePrescription
METFORMIN HYDROCHLORIDE 500MG, SITAGLIPTIN PHOSPHATE EQ 50MG BASE · TABLET · ORAL
JANUMET · ReferencePrescription
METFORMIN HYDROCHLORIDE 1GM, SITAGLIPTIN PHOSPHATE EQ 50MG BASE · TABLET · ORAL
2022-06-21Labeling · Supplement 52 · standard — Letter ↗AP 2021-11-04Labeling · Supplement 51 · standard — Letter ↗AP 2020-12-04Efficacy · Supplement 48 · priority — Label ↗AP 2019-08-12Efficacy · Supplement 46 · standard — Letter ↗AP 2019-07-01Labeling · Supplement 47 · 901 required — Letter ↗AP 2018-02-09Labeling · Supplement 43 · standard — Label ↗AP 2017-08-10Labeling · Supplement 42 · standard — Label ↗AP 2017-01-18Labeling · Supplement 40 · standard — Label ↗AP 2017-01-18Labeling · Supplement 39 · 901 required — Label ↗AP 2015-08-28Labeling · Supplement 35 · 901 required — Label ↗AP 2015-06-12Manufacturing (CMC) · Supplement 33 · standardAP
2015-04-27Labeling · Supplement 34 · standard — Label ↗AP 2015-01-05Manufacturing (CMC) · Supplement 32 · standardAP
2014-03-18Manufacturing (CMC) · Supplement 30 · standardAP
2013-09-11Labeling · Supplement 29 · standard — Label ↗AP 2013-06-28Manufacturing (CMC) · Supplement 28 · standardAP
2013-02-07Labeling · Supplement 27 · standard — Label ↗AP 2012-10-18Labeling · Supplement 26 · unknown — Letter ↗AP 2012-03-24Labeling · Supplement 22 · unknown — Label ↗AP 2011-06-10Labeling · Supplement 15 · unknown — Letter ↗AP 2011-04-14Labeling · Supplement 16 · unknown — Letter ↗AP 2010-09-24Labeling · Supplement 18 · unknown — Letter ↗AP 2010-09-24Efficacy · Supplement 14 · standard — Label ↗AP 2010-02-26Efficacy · Supplement 12 · standard — Letter ↗AP 2010-02-26Efficacy · Supplement 10 · standard — Letter ↗AP 2010-02-26Labeling · Supplement 13 · 901 required — Letter ↗AP 2009-12-28Labeling · Supplement 11 · 901 required — Label ↗AP 2008-10-20Labeling · Supplement 9 · standard — Letter ↗AP 2008-05-01Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP 2008-02-26Efficacy · Supplement 4 · unknown — Label ↗AP 2008-02-26Efficacy · Supplement 3 · unknown — Label ↗AP 2008-01-02Labeling · Supplement 6 · standard — Label ↗AP 2008-01-02Labeling · Supplement 2 · standard — Letter ↗AP 2008-01-02Labeling · Supplement 5 · standard — Letter ↗AP 2007-10-11Manufacturing (CMC) · Supplement 1AP
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.