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FDA ANDA · ANDA077137

TERBINAFINE HYDROCHLORIDE

terbinafine tablets 250 mg

Sponsor: CIPLA

APPLICATION
ANDA077137
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-02
LATEST ACTION
2021-08-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2021-08-09Labeling · Supplement 11 · standardAP
2021-08-09Labeling · Supplement 9 · standardAP
2021-08-09Labeling · Supplement 7 · standardAP
2016-01-10Labeling · Supplement 3 · standardAP
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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