Rocephin W/ Dextrose In Plastic Container

NDA 50624, held by Hoffmann La Roche. Ceftriaxone Sodium.

As of Nov 13, 2026, NDA 50624 (Rocephin W/ Dextrose In Plastic Container), held by Hoffmann La Roche, was first approved by FDA on Feb 11, 1987, with 23 approved supplements and 0 published complete response letters.

First approved: Feb 11, 1987
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Feb 11, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Rocephin W/ Dextrose In Plastic ContainerEQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ceftriaxone Sodium	DiscontinuedReference drug
Rocephin W/ Dextrose In Plastic ContainerEQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ceftriaxone Sodium	DiscontinuedReference drug
Rocephin W/ Dextrose In Plastic ContainerEQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ceftriaxone Sodium	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Sep 14, 2004	Supplement 27Labeling · Standard review	Approved	Label Letter
Sep 2, 2004	Supplement 26Labeling · Standard review	Approved	Letter Label
Nov 21, 2001	Supplement 21Labeling · Standard review	Approved	None posted
Oct 18, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 21, 1997	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 18, 1994	Supplement 17Labeling · Standard review	Approved	None posted
Apr 26, 1994	Supplement 15Labeling	Approved	None posted
Oct 20, 1993	Supplement 18Labeling · Standard review	Approved	None posted
Oct 7, 1993	Supplement 12Labeling	Approved	None posted
Oct 7, 1993	Supplement 11Labeling	Approved	None posted
Mar 1, 1993	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 22, 1993	Supplement 16Labeling · Standard review	Approved	None posted
Dec 4, 1992	Supplement 14Labeling	Approved	None posted
Apr 15, 1991	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 11, 1991	Supplement 10Labeling	Approved	None posted
Mar 11, 1991	Supplement 9Labeling	Approved	None posted
Mar 11, 1991	Supplement 8Labeling	Approved	None posted
Mar 11, 1991	Supplement 6Labeling	Approved	None posted
Nov 14, 1988	Supplement 7Labeling	Approved	None posted
Jun 22, 1987	Supplement 2Labeling	Approved	None posted
Jun 18, 1987	Supplement 4Labeling	Approved	None posted
Jun 18, 1987	Supplement 3Labeling	Approved	None posted
May 22, 1987	Supplement 1Labeling	Approved	None posted
Feb 11, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50624
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