Ceftriaxone

ANDA 65305, held by Epic Pharma LLC. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65305 (Ceftriaxone), held by Epic Pharma LLC, was first approved by FDA on Jan 11, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 11, 2008
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 11, 2008	Original application	Approved	None posted

Products

4 strengths and forms


CeftriaxoneEQ 250MG BASE/VIAL · injectable;intramuscular, intravenous	Ceftriaxone Sodium	Rx
CeftriaxoneEQ 500MG BASE/VIAL · injectable;intramuscular, intravenous	Ceftriaxone Sodium	Rx
CeftriaxoneEQ 1GM BASE/VIAL · injectable;intramuscular, intravenous	Ceftriaxone Sodium	Rx
CeftriaxoneEQ 2GM BASE/VIAL · injectable;intramuscular, intravenous	Ceftriaxone Sodium	Rx

All 5 submissions, including labeling and manufacturing supplements


Jan 13, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Sep 28, 2009	Supplement 2Labeling	Approved	None posted
Sep 28, 2009	Supplement 3Labeling	Approved	None posted
Jan 15, 2009	Supplement 1Labeling	Approved	None posted
Jan 11, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 65305
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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