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NAFTIN

NDA

NAFTIFINE HYDROCHLORIDE | N019599 | LEGACY PHARMA INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Feb 29, 1988

No patent or exclusivity listings for this strength.

#002 — 2%

RLDAB

0 patents0 exclusivities▾

CREAM;TOPICAL | Approved: Jan 13, 2012