`RX
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`DISCN
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`DISCN
`ITRACONAZOLE
`RX
`ITRACONAZOLE
`
`Proprietary Name
`SPORANOX
`ITRACONAZOLE
`ITRACONAZOLE
`ITRACONAZOLE
`ITRACONAZOLE
`ITRACONAZOLE
`ITRACONAZOLE
`ITRACONAZOLE
`ITRACONAZOLE
`SPORANOX
`SPORANOX
`ITRACONAZOLE
`ONMEL
`
`Strength
`Appl No Product Number Dosage Form Route
`100MG
`N020083 001
`CAPSULE
`ORAL
`100MG
`A076104 001
`CAPSULE
`ORAL
`100MG
`A200463 001
`CAPSULE
`ORAL
`100MG
`A205991 001
`CAPSULE
`ORAL
`100MG
`A205080 001
`CAPSULE
`ORAL
`100MG
`A206741 001
`CAPSULE
`ORAL
`100MG
`A205724 001
`CAPSULE
`ORAL
`100MG
`A203445 001
`CAPSULE
`ORAL
`100MG
`A208591 001
`CAPSULE
`ORAL
`N020966 001
`INJECTABLE
`INJECTION 10MG/ML
`N020657 001
`SOLUTION
`ORAL
`10MG/ML
`A205573 001
`SOLUTION
`ORAL
`10MG/ML
`N022484 001
`TABLET
`ORAL
`200MG
`
`TE Code RLD RS Applicant Holder
`AB
`RLD RS JANSSEN PHARMACEUTICALS INC
`AB
`SANDOZ INC
`AB
`MYLAN PHARMACEUTICALS INC
`AB
`ACCORD HEALTHCARE INC
`AB
`AMNEAL PHARMACEUTICALS
`AB
`ALEMBIC PHARMACEUTICALS LTD
`AB
`PAR PHARMACEUTICAL INC
`AB
`JUBILANT GENERICS LTD
`AB
`ALKEM LABORATORIES LTD
`JANSSEN PHARMACEUTICALS INC
`RLD RS JANSSEN PHARMACEUTICALS INC
`AMNEAL PHARMACEUTICALS
`RLD RS SEBELA IRELAND LTD
`
`Approval Date
`Sep 11, 1992
`May 28, 2004
`Jul 20, 2012
`May 26, 2016
`Sep 26, 2016
`Dec 13, 2016
`Dec 13, 2016
`Feb 23, 2017
`Jun 12, 2017
`Mar 30, 1999
`Feb 21, 1997
`Oct 30, 2015
`Apr 29, 2010
`
`Source: "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Search results for Itraconazole." 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 1655
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`
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