FDA NDA · NDA020749

LAMISIL

Sponsor: KARO HLTHCARE

APPLICATION

NDA020749

TYPE

NDA

ORIGINAL APPROVAL

1997-10-17

LATEST ACTION

2003-03-27

ROUTE

TOPICAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

LAMISILDiscontinued

TERBINAFINE HYDROCHLORIDE 1% · SOLUTION · TOPICAL

2003-03-27Labeling · Supplement 4 · standard — Letter ↗AP

2002-08-02Manufacturing (CMC) · Supplement 8 · standardAP

2002-01-22Manufacturing (CMC) · Supplement 7 · standardAP

2001-12-27Manufacturing (CMC) · Supplement 6 · standardAP

2001-04-30Manufacturing (CMC) · Supplement 5 · standardAP

1999-05-13Manufacturing (CMC) · Supplement 2 · standardAP

1997-10-17Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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