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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`U.S. Food and Drug Administration
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`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
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`Product Details for NDA 201023
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`JEVTANA KIT (CABAZITAXEL)
`60MG/1.5ML (40MG/ML)
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`Marketing Status: Prescription
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`Active Ingredient: CABAZITAXEL
`Proprietary Name: JEVTANA KIT
`Dosage Form; Route of Administration: SOLUTION; IV (INFUSION)
`Strength: 60MG/1.5ML (40MG/ML)
`Reference Listed Drug: Yes
`TE Code:
`
`Application Number: N201023
`Product Number: 001
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`Approval Date: Jun 17, 2010
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`Applicant Holder Full Name: SANOFI AVENTIS US INC
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`Marketing Status: Prescription
`Patent and Exclusivi
`Inform ‘on
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`atent info.cfm?
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`http://www.accessdata.fda.gov/scripts/cder/ob/resu|tsJzroduct.cfm?App|_Type=N&App|_No=201023
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`JANSSEN EXHIBIT 2108
`Wockhardt v. Janssen IPR2016-01582
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`