NDA 50587, held by Merck. Cilastatin Sodium; Imipenem.
As of Nov 14, 2026, NDA 50587 (Primaxin), held by Merck, was first approved by FDA on Nov 26, 1985, with 51 approved supplements and 0 published complete response letters.
PRIMAXIN for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. Urinary tract infections. Intra-abdominal infections. Gynecologic infections. Bacterial septicemia. Bone and joint infections. Skin and skin structure infections. Endocarditis. Limitations of Use: PRIMAXIN is not indicated in patients with meningitis because safety and efficacy have not been established. PRIMAXIN is not recommended in pediatric patients with CNS infections because of the risk of seizures.
| Apr 8, 1998 | Supplement 48Efficacy (new indication or use) · Standard review | Approved | |
| Nov 26, 1985 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| PrimaxinEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · powder;intravenous | Cilastatin Sodium; Imipenem | DiscontinuedReference drug |
| PrimaxinEQ 500MG BASE/VIAL;500MG/VIAL · powder;intravenous | Cilastatin Sodium; Imipenem | RxReference drug |
| Jan 30, 2022 | Supplement 83Labeling · Standard review | Approved | |
| Dec 12, 2018 | Supplement 81Labeling · Standard review | Approved | |
| Aug 6, 2018 | Supplement 80Manufacturing | Approved | None posted |
| Dec 16, 2016 | Supplement 74Labeling · Standard review | Approved | |
| Mar 11, 2016 | Supplement 78Manufacturing · Priority review | Approved | None posted |
| Feb 19, 2016 | Supplement 77Manufacturing · Priority review | Approved | None posted |
| Dec 16, 2014 | Supplement 76Labeling · Standard review | Approved | |
| Aug 26, 2014 | Supplement 75Manufacturing · Priority review | Approved | None posted |
| Apr 16, 2012 | Supplement 73Labeling · Standard review | Approved | |
| Aug 26, 2009 | Supplement 72Labeling | Approved | |
| May 8, 2008 | Supplement 70Labeling · Standard review | Approved | |
| Mar 28, 2008 | Supplement 65Labeling · Standard review | Approved | |
| Aug 4, 2006 | Supplement 64Labeling · Standard review | Approved | |
| May 20, 2004 | Supplement 61Labeling · Standard review | Approved | |
| Mar 4, 2003 | Supplement 58Labeling · Standard review | Approved | |
| Jul 9, 2002 | Supplement 59Manufacturing · Priority review | Approved | |
| May 28, 2002 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Nov 30, 2001 | Supplement 53Labeling · Standard review | Approved | |
| Aug 29, 2001 | Supplement 55Manufacturing · Priority review | Approved | |
| Jul 23, 2001 | Supplement 54Manufacturing · Priority review | Approved | |
| Aug 28, 2000 | Supplement 52Labeling · Standard review | Approved | |
| Jul 13, 1999 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Feb 4, 1999 | Supplement 50Labeling · Standard review | Approved | None posted |
| Jul 24, 1998 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Apr 8, 1998 | Supplement 48Efficacy (new indication or use) · Standard review | Approved | |
| Jun 30, 1997 | Supplement 47Labeling · Standard review | Approved | None posted |
| Jan 9, 1997 | Supplement 45Labeling · Standard review | Approved | |
| Sep 19, 1996 | Supplement 46Manufacturing · Priority review | Approved | |
| Sep 12, 1996 | Supplement 39Labeling | Approved | |
| Mar 21, 1995 | Supplement 41Labeling · Standard review | Approved | |
| Mar 10, 1995 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Sep 27, 1994 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Jun 24, 1994 | Supplement 38Labeling | Approved | None posted |
| Mar 7, 1994 | Supplement 26Labeling | Approved | None posted |
| Nov 19, 1993 | Supplement 40Labeling · Standard review | Approved | None posted |
| Nov 4, 1993 | Supplement 33Labeling | Approved | None posted |
| Nov 23, 1992 | Supplement 36Labeling | Approved | None posted |
| Jul 17, 1992 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Jan 14, 1992 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Aug 26, 1991 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Aug 24, 1990 | Supplement 25Labeling | Approved | None posted |
| Mar 30, 1989 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1988 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jun 17, 1988 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| May 20, 1988 | Supplement 20Labeling | Approved | None posted |
| Jan 25, 1988 | Supplement 17Labeling | Approved | None posted |
| Jan 11, 1988 | Supplement 18Labeling | Approved | None posted |
| Oct 8, 1987 | Supplement 13Labeling | Approved | None posted |
| Oct 8, 1987 | Supplement 4Labeling | Approved | None posted |
| Oct 8, 1987 | Supplement 2Labeling | Approved | None posted |
| Oct 29, 1986 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1985 | Original applicationNew molecular entity, new combination · Priority 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
