Ceftriaxone

ANDA 65391, held by Wockhardt Bio AG. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65391 (Ceftriaxone), held by Wockhardt Bio AG, was first approved by FDA on Apr 12, 2007, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 12, 2007
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Apr 12, 2007	Original application	Approved	None posted

Products

3 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Jan 13, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Sep 11, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Mar 2, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Mar 2, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Aug 20, 2012	Supplement 4Labeling	Approved	None posted
Apr 12, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 65391
Drugs@FDA: Overview at FDA
Company: Wockhardt Bio AG

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