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LAMISIL

NDA

TERBINAFINE HYDROCHLORIDE | N022071 | NOVARTIS PHARMACEUTICALS CORP

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 Chain20 active DMFs6 inactive

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

DR REDDYS LABORATORIES LTDTERBINAFINE HYDROCHLORIDE USP

DMF 158872002

HOLIDAY LABS MEXICO SA DE CVTERBINAFINE HYDROCHLORIDE

DMF 161872002

AMINO CHEMICALS LTDTERBINAFINE HYDROCHLORIDE

DMF 162832002

GEDEON RICHTER PLCTERBINAFINE HYDROCHLORIDE USP

DMF 165112003

CIPLA LTDTERBINAFINE HYDROCHLORIDE USP

DMF 173302004

TARO PHARMACEUTICAL INDUSTRIES LTDTERBINAFINE HYDROCHLORIDE USP

DMF 177902004

QUIMICA SINTETICA SATERBINAFINE HYDROCHLORIDE

DMF 179142004

HETERO LABS LTDTERBINAFINE HYDROCHLORIDE

DMF 179872005

APITORIA PHARMA PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP

DMF 181922005

ORBION PHARMACEUTICALS PRIVATE LTDTERBINAFINE HYDROCHLORIDE (NON-STERILE BULK)

DMF 188442005

MSN LABORATORIES PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP [ROUTE CODE - "TF"]

DMF 204132007

ALIVUS LIFE SCIENCES LTDTERBINAFINE HYDROCHLORIDE USP

DMF 212292008

SHANDONG ANHONG PHARMACEUTICAL CO LTDTERBINAFINE HYDROCHLORIDE (NON STERILE, API)

DMF 257052012

TIANJIN WEIJIE PHARMACEUTICAL CO LTDTERBINAFINE HYDROCHLORIDE

DMF 304352016

TARO PHARMACEUTICAL INDUSTRIES LTDTERBINAFINE HYDROCHLORIDE USP

DMF 309402017

CHROMO LABORATORIES INDIA PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP

DMF 317192017

OLON SPATERBINAFINE HYDROCHLORIDE

DMF 324482018

SAPTAGIR LABORATORIES PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP

DMF 376112022

SYNERGENE ACTIVE INGREDIENTS PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP

DMF 377012023

OLON SPATERBINAFINE HYDROCHLORIDE TYPE-2

DMF 383532023

PERRIGO API LTDInactiveTERBINAFINE HYDROCHLORIDE

DMF 167842003

RECORDATI ESPANA SLInactiveTERBINAFINE HYDROCHLORIDE

DMF 172912004

MYLAN LABORATORIES LTDInactiveTERBINAFINE HYDROCHLORIDE USP

DMF 182242005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTERBINAFINE HYDROCHLORIDE

DMF 187582005

AARTI DRUGS LTDInactiveTERBINAFINE HYDROCHLORIDE

DMF 197752006

QILU PHARMACEUTICAL CO LTDInactiveTERBINAFINE HYDROCHLORIDE (NON STERILE, API)

DMF 217172008

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 24, 2017	SUPPL -13	View Letter (PDF)
Aug 23, 2016	SUPPL -11	View Letter (PDF)
Oct 25, 2013	SUPPL -10	View Letter (PDF)
Jun 18, 2013	SUPPL -9	View Letter (PDF)
Apr 25, 2012	SUPPL -7	View Letter (PDF)
Nov 8, 2011	SUPPL -6	View Letter (PDF)
Mar 31, 2011	SUPPL -4	View Letter (PDF)
Dec 7, 2010	SUPPL -3	View Letter (PDF)
Oct 4, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 125MG BASE/PACKET

RLD

0 patents0 exclusivities▴

GRANULE;ORAL | Approved: Sep 28, 2007

No patent or exclusivity listings for this strength.

#002 — EQ 187.5MG BASE/PACKET

RLD

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: Sep 28, 2007