`DISCN
`TERBINAFINE HYDROCHLORIDE
`OTC
`TERBINAFINE HYDROCHLORIDE
`OTC
`TERBINAFINE HYDROCHLORIDE
`DISCN
`TERBINAFINE
`OTC
`TERBINAFINE
`DISCN
`TERBINAFINE HYDROCHLORIDE
`DISCN
`TERBINAFINE HYDROCHLORIDE
`DISCN
`TERBINAFINE HYDROCHLORIDE
`OTC
`TERBINAFINE HYDROCHLORIDE
`OTC
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`DISCN
`TERBINAFINE HYDROCHLORIDE
`DISCN
`TERBINAFINE HYDROCHLORIDE
`DISCN
`TERBINAFINE HYDROCHLORIDE
`DISCN
`TERBINAFINE HYDROCHLORIDE
`DISCN
`TERBINAFINE HYDROCHLORIDE
`RX
`TERBINAFINE HYDROCHLORIDE
`
`Proprietary Name
`LAMISIL
`LAMISIL
`TERBINAFINE HYDROCHLORIDE
`LAMISIL
`LAMISIL AT
`LAMISIL
`LAMISIL
`LAMISIL
`LAMISIL AT
`LAMISIL AT
`LAMISIL
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`TERBINAFINE HYDROCHLORIDE
`
`Strength
`Appl No Product Number Dosage Form Route
`N020192 001
`CREAM
`TOPICAL 1%
`N020980 001
`CREAM
`TOPICAL 1%
`A077511 001
`CREAM
`TOPICAL 1%
`N020846 001
`GEL
`TOPICAL 1%
`N021958 001
`GEL
`TOPICAL 1%
`N022071 001
`GRANULE
`ORAL
`EQ 125MG BASE/PACKET
`N022071 002
`GRANULE
`ORAL
`EQ 187.5MG BASE/PACKET
`N020749 001
`SOLUTION
`TOPICAL 1%
`N021124 001
`SOLUTION
`TOPICAL 1%
`N021124 002
`SPRAY
`TOPICAL 1%
`N020539 001
`TABLET
`ORAL
`EQ 250MG BASE
`A078199 001
`TABLET
`ORAL
`EQ 250MG BASE
`A078297 001
`TABLET
`ORAL
`EQ 250MG BASE
`A077137 001
`TABLET
`ORAL
`EQ 250MG BASE
`A076390 001
`TABLET
`ORAL
`EQ 250MG BASE
`A078157 001
`TABLET
`ORAL
`EQ 250MG BASE
`A077919 001
`TABLET
`ORAL
`EQ 250MG BASE
`A077533 001
`TABLET
`ORAL
`EQ 250MG BASE
`A078163 001
`TABLET
`ORAL
`EQ 250MG BASE
`A076377 001
`TABLET
`ORAL
`EQ 250MG BASE
`A077065 001
`TABLET
`ORAL
`EQ 250MG BASE
`A077136 001
`TABLET
`ORAL
`EQ 250MG BASE
`A077195 001
`TABLET
`ORAL
`EQ 250MG BASE
`A077223 001
`TABLET
`ORAL
`EQ 250MG BASE
`A078229 001
`TABLET
`ORAL
`EQ 250MG BASE
`A077714 001
`TABLET
`ORAL
`EQ 250MG BASE
`
`TE Code RLD RS Applicant Holder
`NOVARTIS PHARMACEUTICALS CORP
`RLD RS GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
`TARO PHARMACEUTICALS USA INC
`GLAXOSMITHKLINE CONSUMER HEALTHCARE
`RLD RS NOVARTIS CONSUMER HEALTH INC
`RLD
`NOVARTIS PHARMACEUTICALS CORP
`RLD
`NOVARTIS PHARMACEUTICALS CORP
`GLAXOSMITHKLINE CONSUMER HEALTHCARE
`RLD RS NOVARTIS CONSUMER HEALTH INC
`RLD RS NOVARTIS CONSUMER HEALTH INC
`RLD RS NOVARTIS PHARMACEUTICALS CORP
`APOTEX CORP
`AUROBINDO PHARMA LTD
`CIPLA LTD
`DR REDDYS LABORATORIES INC
`GLENMARK GENERICS LTD
`HARRIS PHARMACEUTICAL INC
`INVAGEN PHARMACEUTICALS INC
`ORCHID HEALTHCARE
`TEVA PHARMACEUTICALS USA INC
`GEDEON RICHTER USA INC
`MYLAN PHARMACEUTICALS INC
`MYLAN PHARMACEUTICALS INC
`ROXANE LABORATORIES INC
`WOCKHARDT LTD
`BRECKENRIDGE PHARMACEUTICAL INC
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`AB
`
`Approval Date
`Dec 30, 1992
`Mar 9, 1999
`Jul 2, 2007
`Apr 29, 1998
`Jul 24, 2006
`Sep 28, 2007
`Sep 28, 2007
`Oct 17, 1997
`Mar 17, 2000
`Mar 17, 2000
`May 10, 1996
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jul 2, 2007
`Jun 4, 2010
`
`Source: "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Search results for Terbinafine." U.S. Food & Drug. Accessed on November 1, 2017.
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm.
`
`Page 1 of 1
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1657
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`
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