← FDA DRUG APPROVALS

FDA NDA · NDA050517

MEFOXIN

Sponsor: PHARMOBEDIENT

APPLICATION
NDA050517
TYPE
NDA
ORIGINAL APPROVAL
1978-10-18
LATEST ACTION
2017-03-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MEFOXIN · ReferenceDiscontinued
CEFOXITIN SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
MEFOXIN · ReferenceDiscontinued
CEFOXITIN SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
MEFOXIN · ReferenceDiscontinued
CEFOXITIN SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2017-03-09Labeling · Supplement 53 · standard — Label ↗AP
2013-05-10Labeling · Supplement 51 · standard — Letter ↗AP
2011-02-04Labeling · Supplement 50 · unknown — Letter ↗AP
2007-09-17Labeling · Supplement 47 · standard — Letter ↗AP
2004-06-28Labeling · Supplement 45 · standard — Letter ↗AP
2004-06-28Labeling · Supplement 42 · standard — Letter ↗AP
2004-06-02Labeling · Supplement 46 · standard — Label ↗AP
2002-06-06Manufacturing (CMC) · Supplement 44 · priorityAP
2002-05-07Manufacturing (CMC) · Supplement 43 · priorityAP
2001-10-19Manufacturing (CMC) · Supplement 41 · priorityAP
2000-02-14Labeling · Supplement 38 · standard — Review ↗AP
1999-10-12Manufacturing (CMC) · Supplement 40 · priorityAP
1997-04-24Labeling · Supplement 39 · standard — Review ↗AP
1997-02-27Labeling · Supplement 31 — Review ↗AP
1996-10-11Labeling · Supplement 37 · standardAP
1996-07-30Efficacy · Supplement 28AP
1996-05-20Labeling · Supplement 35 · standardAP
1996-05-20Labeling · Supplement 32AP
1995-02-28Efficacy · Supplement 29AP
1994-11-30Manufacturing (CMC) · Supplement 36 · priorityAP
1994-10-27Labeling · Supplement 33 · standardAP
1978-10-18Type 1 - New Molecular Entity · Original · priorityAP
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 →