ANDA 65504, held by Aurobindo Pharma Ltd. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 65504 (Ceftriaxone), held by Aurobindo Pharma Ltd, was first approved by FDA on Jul 31, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CeftriaxoneEQ 10GM BASE/VIAL ยท injectable;injection | Ceftriaxone Sodium | Discontinued |
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
