← FDA DRUG APPROVALS

FDA NDA · NDA021337

ERTAPENEM

ertapenem sodium

Sponsor: MSD SUB MERCK

APPLICATION
NDA021337
TYPE
NDA
ORIGINAL APPROVAL
2001-11-21
LATEST ACTION
2022-03-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INVANZ · ReferencePrescription
ERTAPENEM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS

Approval history

2022-03-17Labeling · Supplement 51 · standard — Letter ↗AP
2020-12-22Labeling · Supplement 49 · standard — Letter ↗AP
2019-09-20Labeling · Supplement 48 · standard — Letter ↗AP
2018-12-19Labeling · Supplement 47 · standard — Label ↗AP
2018-09-12Labeling · Supplement 46 · standard — Letter ↗AP
2017-09-08Labeling · Supplement 45 · standard — Label ↗AP
2015-03-16Manufacturing (CMC) · Supplement 43 · standardAP
2014-09-30Labeling · Supplement 42 · standard — Letter ↗AP
2013-08-05Manufacturing (CMC) · Supplement 40 · standardAP
2013-07-24Labeling · Supplement 41 · standard — Letter ↗AP
2013-01-18Manufacturing (CMC) · Supplement 39 · standardAP
2012-03-02Labeling · Supplement 38 · standard — Letter ↗AP
2012-02-17Labeling · Supplement 37 · standard — Label ↗AP
2011-07-22Labeling · Supplement 31 · standard — Letter ↗AP
2010-05-25Labeling · Supplement 34 · unknown — Label ↗AP
2009-12-13Labeling · Supplement 30 · standard — Label ↗AP
2009-10-06Labeling · Supplement 33 · unknown — Letter ↗AP
2008-03-25Labeling · Supplement 28 · standard — Letter ↗AP
2007-11-16Labeling · Supplement 26 · standard — Letter ↗AP
2006-12-28Manufacturing (CMC) · Supplement 25AP
2006-08-10Efficacy · Supplement 21 · standard — Label ↗AP
2005-10-14Efficacy · Supplement 19 · standard — Label ↗AP
2005-05-18Efficacy · Supplement 18 · priority — Label ↗AP
2005-01-24Labeling · Supplement 17 · standard — Letter ↗AP
2004-09-10Labeling · Supplement 15 · standard — Letter ↗AP
2004-05-20Labeling · Supplement 14 · standard — Letter ↗AP
2004-04-30Labeling · Supplement 13 · standard — Letter ↗AP
2002-12-20Manufacturing (CMC) · Supplement 4 · standardAP
2002-07-09Manufacturing (CMC) · Supplement 3 · standardAP
2002-05-09Manufacturing (CMC) · Supplement 2 · standardAP
2002-05-09Manufacturing (CMC) · Supplement 1 · standardAP
2001-11-21Type 1 - New Molecular Entity · Original · standard — Label ↗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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