JANUVIA · ReferencePrescription
SITAGLIPTIN PHOSPHATE EQ 50MG BASE · TABLET · ORAL
JANUVIA · ReferencePrescription
SITAGLIPTIN PHOSPHATE EQ 100MG BASE · TABLET · ORAL
JANUVIA · ReferencePrescription
SITAGLIPTIN PHOSPHATE EQ 25MG BASE · TABLET · ORAL
2023-12-28Manufacturing (CMC) · Supplement 53 — Label ↗AP 2022-06-21Labeling · Supplement 50 · standard — Letter ↗AP 2020-12-04Efficacy · Supplement 47 · priority — Label ↗AP 2019-08-12Efficacy · Supplement 45 · standard — Letter ↗AP 2019-07-01Labeling · Supplement 46 · 901 required — Letter ↗AP 2018-02-09Labeling · Supplement 42 · standard — Label ↗AP 2017-08-10Labeling · Supplement 40 · standard — Label ↗AP 2017-01-18Labeling · Supplement 38 · standard — Label ↗AP 2016-01-11Manufacturing (CMC) · Supplement 35 · standardAP
2015-08-28Labeling · Supplement 34 · 901 required — Label ↗AP 2015-04-27Labeling · Supplement 33 · standard — Label ↗AP 2015-03-10Manufacturing (CMC) · Supplement 32 · standard — Letter ↗AP 2013-10-17Manufacturing (CMC) · Supplement 28 · standard — Label ↗AP 2013-08-19Labeling · Supplement 29 · standard — Letter ↗AP 2013-02-11Labeling · Supplement 27 · standard — Label ↗AP 2012-12-07Manufacturing (CMC) · Supplement 26 · standardAP
2012-10-18Labeling · Supplement 25 · unknown — Label ↗AP 2012-03-24Labeling · Supplement 23 · unknown — Letter ↗AP 2012-02-27Manufacturing (CMC) · Supplement 19 — Label ↗AP 2011-06-10Labeling · Supplement 16 · unknown — Letter ↗AP 2011-04-14Labeling · Supplement 17 · unknown — Letter ↗AP 2010-09-24Efficacy · Supplement 15 · standard — Label ↗AP 2010-09-24Labeling · Supplement 18 · unknown — Letter ↗AP 2010-02-26Efficacy · Supplement 11 · standard — Letter ↗AP 2010-02-26Labeling · Supplement 14 · 901 required — Review ↗AP 2010-02-26Efficacy · Supplement 12 · standard — Label ↗AP 2010-02-26Efficacy · Supplement 10 · standard — Label ↗AP 2009-12-28Labeling · Supplement 13 · 901 required — Label ↗AP 2008-10-20Labeling · Supplement 9 · standard — Letter ↗AP 2008-07-22Labeling · Supplement 7 · standard — Letter ↗AP 2007-10-12Labeling · Supplement 6 · standard — Letter ↗AP 2007-10-12Labeling · Supplement 4 · standard — Letter ↗AP 2007-10-12Efficacy · Supplement 2 · unknown — Letter ↗AP 2007-10-12Efficacy · Supplement 3 · unknown — Letter ↗AP 2007-04-10Manufacturing (CMC) · Supplement 1AP
2006-10-16Type 1 - New Molecular Entity · Original · standard — Label ↗AP 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.