NDA 21337, held by Msd Sub Merck. Ertapenem Sodium.
As of Nov 15, 2026, NDA 21337 (Invanz), held by Msd Sub Merck, was first approved by FDA on Nov 21, 2001, with 31 approved supplements and 0 published complete response letters.
INVANZ is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. Community-acquired pneumonia. Complicated urinary tract infections including pyelonephritis. Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
| Aug 10, 2006 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 2005 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| May 18, 2005 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Nov 21, 2001 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| InvanzEQ 1GM BASE/VIAL · injectable;intramuscular, intravenous | Ertapenem Sodium | RxReference drug |
| Mar 17, 2022 | Supplement 51Labeling · Standard review | Approved | |
| Dec 22, 2020 | Supplement 49Labeling · Standard review | Approved | |
| Sep 20, 2019 | Supplement 48Labeling · Standard review | Approved | |
| Dec 19, 2018 | Supplement 47Labeling · Standard review | Approved | |
| Sep 12, 2018 | Supplement 46Labeling · Standard review | Approved | |
| Sep 8, 2017 | Supplement 45Labeling · Standard review | Approved | |
| Mar 16, 2015 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Sep 30, 2014 | Supplement 42Labeling · Standard review | Approved | |
| Aug 5, 2013 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jul 24, 2013 | Supplement 41Labeling · Standard review | Approved | |
| Jan 18, 2013 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 2, 2012 | Supplement 38Labeling · Standard review | Approved | |
| Feb 17, 2012 | Supplement 37Labeling · Standard review | Approved | |
| Jul 22, 2011 | Supplement 31Labeling · Standard review | Approved | |
| May 25, 2010 | Supplement 34Labeling | Approved | |
| Dec 13, 2009 | Supplement 30Labeling · Standard review | Approved | |
| Oct 6, 2009 | Supplement 33Labeling | Approved | |
| Mar 25, 2008 | Supplement 28Labeling · Standard review | Approved | |
| Nov 16, 2007 | Supplement 26Labeling · Standard review | Approved | |
| Dec 28, 2006 | Supplement 25Manufacturing | Approved | None posted |
| Aug 10, 2006 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 2005 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| May 18, 2005 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Jan 24, 2005 | Supplement 17Labeling · Standard review | Approved | |
| Sep 10, 2004 | Supplement 15Labeling · Standard review | Approved | |
| May 20, 2004 | Supplement 14Labeling · Standard review | Approved | |
| Apr 30, 2004 | Supplement 13Labeling · Standard review | Approved | |
| Dec 20, 2002 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 9, 2002 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 9, 2002 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 9, 2002 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 21, 2001 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
