← FDA DRUG APPROVALS

FDA ANDA · ANDA061763

VELOSEF '250'

Sponsor: APOTHECON

APPLICATION
ANDA061763
TYPE
ANDA
ORIGINAL APPROVAL
1974-08-19
LATEST ACTION
1993-03-24
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

VELOSEF '250'Discontinued
CEPHRADINE 250MG/5ML · FOR SUSPENSION · ORAL
VELOSEF '125'Discontinued
CEPHRADINE 125MG/5ML · FOR SUSPENSION · ORAL

Approval history

1993-03-24Manufacturing (CMC) · Supplement 18AP
1993-03-24Manufacturing (CMC) · Supplement 19AP
1993-03-24Manufacturing (CMC) · Supplement 17AP
1987-07-09Manufacturing (CMC) · Supplement 16AP
1974-08-19OriginalAP
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 →