NDA 50585, held by Hoffmann La Roche. Ceftriaxone Sodium, Ceftriaxone Sodium; Lidocaine.
As of Nov 13, 2026, NDA 50585 (Rocephin, Rocephin Kit), held by Hoffmann La Roche, was first approved by FDA on Dec 21, 1984, with 46 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 1997 | Supplement 46Efficacy (new indication or use) · Standard review | Approved | None posted |
| May 8, 1996 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | None posted |
| May 28, 1993 | Supplement 34Efficacy (new indication or use) | Approved | None posted |
| Jun 17, 1992 | Supplement 35Efficacy (new indication or use) | Approved | None posted |
| Feb 11, 1992 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Nov 22, 1991 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Dec 31, 1990 | Supplement 27Efficacy (new indication or use) | Approved | None posted |
| Dec 21, 1984 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| RocephinEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intramuscular, intravenous | Ceftriaxone Sodium | DiscontinuedReference drug |
| RocephinEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intramuscular, intravenous | Ceftriaxone Sodium | DiscontinuedReference drug |
| RocephinEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intramuscular, intravenous | Ceftriaxone Sodium | DiscontinuedReference drug |
| RocephinEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intramuscular, intravenous | Ceftriaxone Sodium | DiscontinuedReference drug |
| RocephinEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ceftriaxone Sodium | DiscontinuedReference drug |
| Rocephin KitEQ 1GM BASE/VIAL,N/A;N/A,1% · injectable;injection | Ceftriaxone Sodium; Lidocaine | Discontinued |
| Rocephin KitEQ 500MG BASE/VIAL,N/A;N/A,1% · injectable;injection | Ceftriaxone Sodium; Lidocaine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 12, 2018 | Supplement 68Labeling · Standard review | Approved | |
| Jun 30, 2015 | Supplement 67Labeling · Standard review | Approved | |
| Mar 20, 2015 | Supplement 66Labeling · Standard review | Approved | |
| Apr 12, 2013 | Supplement 65Labeling · Standard review | Approved | |
| Nov 12, 2010 | Supplement 62Labeling · Standard review | Approved | |
| Feb 25, 2010 | Supplement 64Labeling | Approved | |
| Jun 7, 2009 | Supplement 63Labeling · Standard review | Approved | |
| Mar 11, 2009 | Supplement 61Labeling · Standard review | Approved | |
| Aug 18, 2008 | Supplement 50Labeling · Standard review | Approved | |
| Aug 18, 2008 | Supplement 60Labeling · Standard review | Approved | |
| Jul 17, 2007 | Supplement 58Labeling · Standard review | Approved | |
| May 11, 2007 | Supplement 59Labeling · Standard review | Approved | |
| Sep 14, 2004 | Supplement 57Labeling · Standard review | Approved | |
| Sep 2, 2004 | Supplement 56Labeling · Standard review | Approved | |
| Mar 29, 2004 | Supplement 54Labeling · Standard review | Approved | |
| Aug 25, 2000 | Supplement 47Labeling · Standard review | Approved | None posted |
| Oct 18, 1999 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Apr 28, 1998 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Dec 23, 1997 | Supplement 46Efficacy (new indication or use) · Standard review | Approved | None posted |
| May 8, 1996 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 14, 1996 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Sep 14, 1995 | Supplement 45Labeling · Standard review | Approved | None posted |
| Aug 18, 1994 | Supplement 43Labeling · Standard review | Approved | None posted |
| Apr 26, 1994 | Supplement 39Labeling | Approved | None posted |
| Feb 4, 1994 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Oct 7, 1993 | Supplement 33Labeling | Approved | None posted |
| May 28, 1993 | Supplement 34Efficacy (new indication or use) | Approved | None posted |
| Feb 8, 1993 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Sep 23, 1992 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jun 17, 1992 | Supplement 35Efficacy (new indication or use) | Approved | None posted |
| Feb 11, 1992 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Feb 4, 1992 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Jan 31, 1992 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1991 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Sep 12, 1991 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Mar 11, 1991 | Supplement 26Labeling | Approved | None posted |
| Mar 11, 1991 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Mar 11, 1991 | Supplement 18Labeling | Approved | None posted |
| Dec 31, 1990 | Supplement 27Efficacy (new indication or use) | Approved | None posted |
| Sep 25, 1989 | Supplement 15Labeling | Approved | None posted |
| Jun 29, 1989 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Feb 7, 1989 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Aug 26, 1988 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Oct 7, 1986 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Oct 7, 1986 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| May 10, 1985 | Supplement 4Labeling | Approved | None posted |
| Dec 21, 1984 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
