ANDA 210197, held by Regcon Holdings. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 210197 (Ceftriaxone), held by Regcon Holdings, was first approved by FDA on Jan 12, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2024 | 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 |
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
