← FDA DRUG APPROVALS

FDA NDA · NDA050613

CEFOBID IN PLASTIC CONTAINER

Sponsor: PFIZER

APPLICATION
NDA050613
TYPE
NDA
ORIGINAL APPROVAL
1986-07-23
LATEST ACTION
1998-06-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFOBID IN PLASTIC CONTAINERDiscontinued
CEFOPERAZONE SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION
CEFOBID IN PLASTIC CONTAINERDiscontinued
CEFOPERAZONE SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION

Approval history

1998-06-01Manufacturing (CMC) · Supplement 8 · standardAP
1996-12-03Manufacturing (CMC) · Supplement 6 · standardAP
1994-10-28Labeling · Supplement 7 · standardAP
1989-08-01Manufacturing (CMC) · Supplement 5 · standardAP
1988-09-29Labeling · Supplement 1AP
1988-07-20Labeling · Supplement 2AP
1987-11-10Manufacturing (CMC) · Supplement 4 · standardAP
1987-07-31Manufacturing (CMC) · Supplement 3 · standardAP
1986-07-23Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →