Assyro AI

Orange Book product · Brand (NDA)

LOTRIMIN ULTRA

BUTENAFINE HYDROCHLORIDE

Brand (NDA)NDA 021307OTC BAYER HEALTHCARE LLC
View BUTENAFINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Dec 07, 2001

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 07, 2001

    24 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BUTENAFINE HYDROCHLORIDE

Strength

1%

Dosage form

CREAM

Route

TOPICAL

TE code

Not listed

Application

NDA 021307

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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