APPLICATION
ANDA062178
TYPE
ANDA
ORIGINAL APPROVAL
1980-03-13
LATEST ACTION
1994-01-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GRISACTIN ULTRADiscontinued
GRISEOFULVIN, ULTRAMICROCRYSTALLINE 250MG · TABLET · ORAL
GRISACTIN ULTRADiscontinued
GRISEOFULVIN, ULTRAMICROCRYSTALLINE 125MG · TABLET · ORAL
Approval history
1994-01-31Manufacturing (CMC) · Supplement 15AP
1991-09-03Manufacturing (CMC) · Supplement 12AP
1991-06-20Bioequivalence · Supplement 14AP
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.