Rocephin

ANDA 63239, held by Hoffmann La Roche. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 63239 (Rocephin), held by Hoffmann La Roche, was first approved by FDA on Aug 13, 1993, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 13, 1993
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 13, 1993	Original application	Approved	None posted

Products

3 strengths and forms


RocephinEQ 250MG BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Discontinued
RocephinEQ 500MG BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Discontinued
RocephinEQ 1GM BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 25, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Apr 14, 2006	Supplement 5Labeling	Approved	None posted
Dec 20, 1999	Supplement 3Manufacturing	Approved	None posted
Aug 26, 1994	Supplement 2Manufacturing	Approved	None posted
Apr 14, 1994	Supplement 1Labeling	Approved	None posted
Aug 13, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 63239
Drugs@FDA: Overview at FDA
Company: Hoffmann-La Roche

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