← FDA DRUG APPROVALS

FDA NDA · NDA050482

KEFLIN

Sponsor: LILLY

APPLICATION
NDA050482
TYPE
NDA
ORIGINAL APPROVAL
1974-12-18
LATEST ACTION
1993-01-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

KEFLINDiscontinued
CEPHALOTHIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
KEFLINDiscontinued
CEPHALOTHIN SODIUM EQ 20GM BASE/VIAL · INJECTABLE · INJECTION
KEFLINDiscontinued
CEPHALOTHIN SODIUM EQ 4GM BASE/VIAL · INJECTABLE · INJECTION
KEFLINDiscontinued
CEPHALOTHIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

1993-01-19Labeling · Supplement 27 · standardAP
1987-03-20Manufacturing (CMC) · Supplement 24 · standardAP
1986-10-30Manufacturing (CMC) · Supplement 21 · standardAP
1985-12-17Labeling · Supplement 19 · standardAP
1985-11-25Efficacy · Supplement 18 · standardAP
1985-06-07Manufacturing (CMC) · Supplement 17 · standardAP
1985-05-08Manufacturing (CMC) · Supplement 16 · standardAP
1984-09-07Manufacturing (CMC) · Supplement 15 · standardAP
1984-03-08Manufacturing (CMC) · Supplement 14 · standardAP
1983-12-05Labeling · Supplement 13 · standardAP
1983-10-05Manufacturing (CMC) · Supplement 12 · standardAP
1983-08-24Labeling · Supplement 11 · standardAP
1983-08-05Labeling · Supplement 9 · standardAP
1983-08-05Labeling · Supplement 10 · standardAP
1983-06-21Labeling · Supplement 8 · standardAP
1983-06-20Labeling · Supplement 7 · standardAP
1983-03-18Labeling · Supplement 6 · standardAP
1983-03-08Labeling · Supplement 5 · standardAP
1983-02-17Manufacturing (CMC) · Supplement 4 · standardAP
1983-02-01Manufacturing (CMC) · Supplement 3 · standardAP
1983-01-13Manufacturing (CMC) · Supplement 2 · standardAP
1982-11-17Manufacturing (CMC) · Supplement 1 · standardAP
1974-12-18Type 3 - New Dosage Form · Original · standardAP
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 →