APPLICATION
NDA050448
TYPE
NDA
ORIGINAL APPROVAL
1972-05-30
LATEST ACTION
1998-10-08
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
GRIFULVIN V · ReferenceDiscontinued
GRISEOFULVIN, MICROCRYSTALLINE 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL
Approval history
1998-10-08Manufacturing (CMC) · Supplement 4AP
1972-05-30UNKNOWN · Original · unknownAP
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.