← FDA DRUG APPROVALS

FDA ANDA · ANDA203924

PRIMAQUINE PHOSPHATE

Sponsor: ALVOGEN

APPLICATION
ANDA203924
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-03
LATEST ACTION
2025-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PRIMAQUINE PHOSPHATEDiscontinued
PRIMAQUINE PHOSPHATE EQ 15MG BASE · TABLET · ORAL

Approval history

2025-08-15Labeling · Supplement 1 · standardAP
2014-02-03UNKNOWN · OriginalLetterAP
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 →