APPLICATION
ANDA078163
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-02
LATEST ACTION
2025-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TERBINAFINE HYDROCHLORIDEPrescription
TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
Approval history
2025-09-12Labeling · Supplement 12 · standardAP
2025-09-12Labeling · Supplement 10 · standardAP
2025-09-12Labeling · Supplement 9 · standardAP
2015-09-24Labeling · Supplement 8 · standardAP
2015-09-24Labeling · Supplement 7 · standardAP
2012-07-12Labeling · Supplement 6 · standardAP
2012-07-12Labeling · Supplement 5 · standardAP
2011-12-14Labeling · Supplement 2AP
2011-12-13Labeling · Supplement 3AP
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.
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