ANDA 65505, held by Aurobindo Pharma Ltd. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 65505 (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 |
| 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 |
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
