ANDA 65002, held by Fresenius Kabi USA. Cefuroxime Sodium.
As of Nov 15, 2026, ANDA 65002 (Cefuroxime Sodium), held by Fresenius Kabi USA, was first approved by FDA on Sep 28, 1998, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cefuroxime SodiumEQ 7.5GM BASE/VIAL ยท injectable;injection | Cefuroxime Sodium | Discontinued |
| Sep 29, 2009 | Supplement 7Labeling | Approved | None posted |
| Mar 31, 2008 | Supplement 6Labeling | Approved | None posted |
| Feb 20, 2004 | Supplement 4Labeling | Approved | None posted |
| Apr 30, 2003 | Supplement 3Labeling | Approved | None posted |
| Oct 10, 2002 | Supplement 2Labeling | Approved | None posted |
| Mar 28, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Sep 28, 1998 | 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
