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NAFTIFINE HYDROCHLORIDE

ANDA

NAFTIFINE HYDROCHLORIDE | A208201 | SUN PHARMA CANADA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: NAFTIN(TE code: AB)

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

ERREGIERRE SPANAFTIFINE HYDROCHLORIDE USP

DMF 147112000

NOVARTIS PHARMA AGNAFTIFINE HYDROCHLORIDE

DMF 167722003

OLON SPANAFTIFINE HYDROCHLORIDE

DMF 181472005

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTDNAFTIFINE HYDROCHLORIDE

DMF 234562010

TARO PHARMACEUTICAL INDUSTRIES LTDNAFTIFINE HYDROCHLORIDE USP

DMF 246192012

CHONGQING HUAPONT PHARMACEUTICAL CO LTDNAFTIFINE HYDROCHLORIDE

DMF 287352014

MSN LABORATORIES PRIVATE LTDNAFTIFINE HYDROCHLORIDE USP [ROUTE CODE "NT"]

DMF 289312015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 22, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Apr 10, 2019

No patent or exclusivity listings for this strength.