← FDA DRUG APPROVALS

FDA ANDA · ANDA204371

ULTRAMICROSIZE GRISEOFULVIN

ultramicrosize griseofulvin tablets

Sponsor: MOUNTAIN

APPLICATION
ANDA204371
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-09
LATEST ACTION
2025-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GRISEOFULVIN, ULTRAMICROSIZEPrescription
GRISEOFULVIN, ULTRAMICROSIZE 125MG · TABLET · ORAL
GRISEOFULVIN, ULTRAMICROSIZEPrescription
GRISEOFULVIN, ULTRAMICROSIZE 250MG · TABLET · ORAL

Approval history

2025-03-20Labeling · Supplement 1 · standardAP
2014-01-09UNKNOWN · OriginalAP
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 →