Ceftriaxone

ANDA 91068, held by Agila Speclts. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 91068 (Ceftriaxone), held by Agila Speclts, was first approved by FDA on Jan 7, 2013, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 7, 2013
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 7, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CeftriaxoneEQ 10GM BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 27, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Jan 7, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 91068
Drugs@FDA: Overview at FDA
Company: Agila Speclts

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