← FDA DRUG APPROVALS

FDA ANDA · ANDA062986

CEPHALEXIN

Sponsor: APOTHECON

APPLICATION
ANDA062986
TYPE
ANDA
ORIGINAL APPROVAL
1991-04-18
LATEST ACTION
1998-06-30
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

CEPHALEXINDiscontinued
CEPHALEXIN EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

1998-06-30Manufacturing (CMC) · Supplement 5AP
1996-05-16Labeling · Supplement 4AP
1996-01-29Manufacturing (CMC) · Supplement 3AP
1996-01-29Manufacturing (CMC) · Supplement 1AP
1996-01-29Manufacturing (CMC) · Supplement 2AP
1991-04-18OriginalAP
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 →