APPLICATION
ANDA078199
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-02
LATEST ACTION
2020-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TERBINAFINE HYDROCHLORIDEPrescription
TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
Approval history
2020-02-28Labeling · Supplement 9 · standardAP
2020-02-28Labeling · Supplement 11 · standardAP
2020-02-28Labeling · Supplement 10 · standardAP
2015-08-25Labeling · Supplement 8 · standardAP
2013-02-19Labeling · Supplement 5 · standardAP
2012-07-12Labeling · Supplement 4AP
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.