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FDA ANDA · ANDA076377

TERBINAFINE HYDROCHLORIDE

Sponsor: HERITAGE PHARMA AVET

APPLICATION
ANDA076377
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-02
LATEST ACTION
2021-08-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TERBINAFINE HYDROCHLORIDEDiscontinued
TERBINAFINE HYDROCHLORIDE EQ 250MG BASE · TABLET · ORAL

Approval history

2021-08-31Labeling · Supplement 5 · standardAP
2021-08-31Labeling · Supplement 6 · standardAP
2011-02-08Labeling · Supplement 3AP
2007-07-02Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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