← FDA DRUG APPROVALS

FDA ANDA · ANDA077938

MELOXICAM

Sponsor: PURACAP PHARM

APPLICATION
ANDA077938
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-19
LATEST ACTION
2024-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MELOXICAMPrescription
MELOXICAM 15MG · TABLET · ORAL
MELOXICAMPrescription
MELOXICAM 7.5MG · TABLET · ORAL

Approval history

2024-12-16Labeling · Supplement 6 · standardAP
2024-12-12Labeling · Supplement 5 · standardAP
2019-11-13Labeling · Supplement 4 · standardAP
2006-07-19OriginalLetterAP
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 →