APPLICATION
ANDA061996
TYPE
ANDA
ORIGINAL APPROVAL
1982-04-06
LATEST ACTION
2001-01-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FULVICIN P/G 330Prescription
GRISEOFULVIN, ULTRAMICROSIZE 330MG · TABLET · ORAL
FULVICIN P/GPrescription
GRISEOFULVIN, ULTRAMICROSIZE 250MG · TABLET · ORAL
FULVICIN P/G 165Prescription
GRISEOFULVIN, ULTRAMICROSIZE 165MG · TABLET · ORAL
FULVICIN P/GPrescription
GRISEOFULVIN, ULTRAMICROSIZE 125MG · TABLET · ORAL
Approval history
2001-01-26Manufacturing (CMC) · Supplement 7AP
1982-04-06OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.