← FDA DRUG APPROVALS

FDA ANDA · ANDA062654

ROCEPHIN

Sponsor: HOFFMANN LA ROCHE

APPLICATION
ANDA062654
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-30
LATEST ACTION
2004-07-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ROCEPHINDiscontinued
CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
ROCEPHINDiscontinued
CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
ROCEPHINDiscontinued
CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2004-07-30Labeling · Supplement 26AP
2004-07-26Labeling · Supplement 24AP
2004-04-28Labeling · Supplement 23AP
2002-08-13Manufacturing (CMC) · Supplement 19AP
2001-08-22Labeling · Supplement 18AP
1999-12-20Manufacturing (CMC) · Supplement 17AP
1998-09-18Manufacturing (CMC) · Supplement 16AP
1996-06-04Manufacturing (CMC) · Supplement 15AP
1996-02-28Manufacturing (CMC) · Supplement 5AP
1995-07-24Labeling · Supplement 8AP
1994-04-14Labeling · Supplement 14AP
1994-02-23Manufacturing (CMC) · Supplement 13AP
1993-04-02Manufacturing (CMC) · Supplement 9AP
1993-03-23Labeling · Supplement 10AP
1993-01-15Manufacturing (CMC) · Supplement 11AP
1992-08-31Labeling · Supplement 7AP
1992-07-22Manufacturing (CMC) · Supplement 4AP
1992-06-01Manufacturing (CMC) · Supplement 2AP
1987-04-30Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →