Ceftriaxone

ANDA 91049, held by Astral. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 91049 (Ceftriaxone), held by Astral, was first approved by FDA on Jun 11, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 11, 2018
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
Jun 11, 2018	Original application	Approved	None posted

Products

4 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jan 13, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Jun 11, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 91049
Drugs@FDA: Overview at FDA
Company: Astral

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