FDA NDA · NDA020524

MENTAX

Sponsor: PHARMOBEDIENT

APPLICATION

NDA020524

TYPE

NDA

ORIGINAL APPROVAL

1996-10-18

LATEST ACTION

2002-06-17

ROUTE

TOPICAL

DOSAGE FORM

CREAM

MARKETING STATUS

Discontinued

Products

MENTAX · ReferenceDiscontinued

BUTENAFINE HYDROCHLORIDE 1% · CREAM · TOPICAL

2002-06-17Manufacturing (CMC) · Supplement 7 · standardAP

2001-06-06Efficacy · Supplement 5 · standard — Review ↗AP

1999-11-01Manufacturing (CMC) · Supplement 4 · standardAP

1997-12-31Manufacturing (CMC) · Supplement 3 · standardAP

1997-11-25Efficacy · Supplement 1 · standardAP

1997-03-11Manufacturing (CMC) · Supplement 2 · standardAP

1996-10-18Type 1 - New Molecular Entity · 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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