Rocephin

ANDA 62654, held by Hoffmann La Roche. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 62654 (Rocephin), held by Hoffmann La Roche, was first approved by FDA on Apr 30, 1987, with 18 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1987
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Apr 30, 1987	Original application	Approved	None posted

Products

3 strengths and forms


RocephinEQ 500MG BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Discontinued
RocephinEQ 1GM BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Discontinued
RocephinEQ 2GM BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Jul 30, 2004	Supplement 26Labeling	Approved	None posted
Jul 26, 2004	Supplement 24Labeling	Approved	None posted
Apr 28, 2004	Supplement 23Labeling	Approved	None posted
Aug 13, 2002	Supplement 19Manufacturing	Approved	None posted
Aug 22, 2001	Supplement 18Labeling	Approved	None posted
Dec 20, 1999	Supplement 17Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 16Manufacturing	Approved	None posted
Jun 4, 1996	Supplement 15Manufacturing	Approved	None posted
Feb 28, 1996	Supplement 5Manufacturing	Approved	None posted
Jul 24, 1995	Supplement 8Labeling	Approved	None posted
Apr 14, 1994	Supplement 14Labeling	Approved	None posted
Feb 23, 1994	Supplement 13Manufacturing	Approved	None posted
Apr 2, 1993	Supplement 9Manufacturing	Approved	None posted
Mar 23, 1993	Supplement 10Labeling	Approved	None posted
Jan 15, 1993	Supplement 11Manufacturing	Approved	None posted
Aug 31, 1992	Supplement 7Labeling	Approved	None posted
Jul 22, 1992	Supplement 4Manufacturing	Approved	None posted
Jun 1, 1992	Supplement 2Manufacturing	Approved	None posted
Apr 30, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 62654
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