ANDA 65125, held by Lupin. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 65125 (Ceftriaxone), held by Lupin, was first approved by FDA on Sep 30, 2003, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 2003 | Original application | Approved |
| CeftriaxoneEQ 250MG BASE/VIAL · injectable;intramuscular, intravenous | Ceftriaxone Sodium | Discontinued |
| CeftriaxoneEQ 500MG BASE/VIAL · injectable;intramuscular, intravenous | Ceftriaxone Sodium | Discontinued |
| CeftriaxoneEQ 1GM BASE/VIAL · injectable;intramuscular, intravenous | Ceftriaxone Sodium | Discontinued |
| CeftriaxoneEQ 2GM BASE/VIAL · injectable;intramuscular, intravenous | Ceftriaxone Sodium | Discontinued |
| Jan 13, 2022 | Supplement 30Labeling · Standard review | Approved | None posted |
| Sep 23, 2020 | Supplement 28Labeling · Standard review | Approved | None posted |
| Sep 23, 2020 | Supplement 29Labeling · Standard review | Approved | None posted |
| May 27, 2016 | Supplement 17Labeling · Standard review | Approved | None posted |
| May 27, 2016 | Supplement 19Labeling · Standard review | Approved | None posted |
| May 27, 2016 | Supplement 22Labeling · Standard review | Approved | None posted |
| Mar 6, 2013 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jun 29, 2010 | Supplement 10Labeling | Approved | None posted |
| Jan 27, 2010 | Supplement 8Labeling | Approved | None posted |
| Jul 9, 2008 | Supplement 6Labeling | Approved | None posted |
| Sep 1, 2005 | Supplement 3Labeling | Approved | None posted |
| Sep 30, 2003 | Original application | 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
