ANDA 65252, held by Fresenius Kabi USA. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 65252 (Ceftriaxone), held by Fresenius Kabi USA, was first approved by FDA on Feb 15, 2006, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 15, 2006 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CeftriaxoneEQ 10GM BASE/VIAL ยท injectable;injection | Ceftriaxone Sodium | Discontinued |
| May 7, 2009 | Supplement 3Labeling | Approved | None posted |
| Jan 15, 2009 | Supplement 2Labeling | Approved | None posted |
| Feb 15, 2006 | Original application | 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
