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BUTENAFINE HYDROCHLORIDE

ANDA

BUTENAFINE HYDROCHLORIDE | A205181 | SUN PHARMA CANADA INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ERREGIERRE SPABUTENAFINE HYDROCHLORIDE

DMF 187072005

TARO PHARMACEUTICAL INDUSTRIES LTDBUTENAFINE HYDROCHLORIDE

DMF 195512006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 18, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Nov 16, 2017

No patent or exclusivity listings for this strength.