APPLICATION
ANDA078157
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-02
LATEST ACTION
2014-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TERBINAFINE HYDROCHLORIDEPrescription
TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
Approval history
2014-10-16Manufacturing (CMC) · Supplement 4AP
2008-08-13Labeling · Supplement 2AP
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.