NDA 50679, held by Hospira Inc. Cefepime Hydrochloride.
As of Nov 13, 2026, NDA 50679 (Maxipime), held by Hospira Inc, was first approved by FDA on Jan 18, 1996, with 33 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2003 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 1998 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| May 16, 1997 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 1996 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| MaxipimeEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefepime Hydrochloride | DiscontinuedReference drug |
| MaxipimeEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefepime Hydrochloride | DiscontinuedReference drug |
| MaxipimeEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefepime Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2021 | Supplement 46Labeling · Standard review | Approved | |
| May 3, 2017 | Supplement 42Labeling · Standard review | Approved | |
| Jun 22, 2016 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Mar 4, 2016 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 1, 2016 | Supplement 40Labeling · Standard review | Approved | |
| Jun 12, 2014 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| May 1, 2014 | Supplement 31Labeling · Standard review | Approved | |
| Mar 15, 2013 | Supplement 34Labeling | Approved | |
| Sep 6, 2012 | Supplement 36Labeling · Standard review | Approved | |
| Sep 30, 2009 | Supplement 32Labeling · Standard review | Approved | |
| Sep 14, 2007 | Supplement 28Labeling · Standard review | Approved | |
| Sep 14, 2007 | Supplement 24Labeling · Standard review | Approved | |
| Jun 9, 2004 | Supplement 23Labeling · Standard review | Approved | |
| Mar 17, 2003 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Aug 21, 2002 | Supplement 18Labeling · Standard review | Approved | |
| Aug 21, 2002 | Supplement 14Labeling · Standard review | Approved | |
| Aug 21, 2002 | Supplement 9Labeling · Standard review | Approved | |
| Mar 15, 2002 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 20, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 2, 2001 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Sep 20, 2000 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 26, 2000 | Supplement 15Labeling · Standard review | Approved | None posted |
| May 10, 2000 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1999 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 27, 1999 | Supplement 7Labeling · Standard review | Approved | |
| Nov 24, 1998 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1998 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1998 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1998 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| Oct 20, 1997 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 16, 1997 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 23, 1996 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 13, 1996 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1996 | 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
