APPLICATION
ANDA076390
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-02
LATEST ACTION
2012-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TERBINAFINE HYDROCHLORIDEPrescription
TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL
Approval history
2012-06-28Labeling · Supplement 6 · standardAP
2012-04-10Labeling · Supplement 5AP
2011-11-10Labeling · Supplement 4AP
2011-09-20Labeling · 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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