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`U.S. Food and Drug Administration
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`Orange Book: Approved Drug Products
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`Product Details for NBA 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
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`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 Exclusivit
`Information
`atent info.cfm?
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`http://www.accessdata.fda.gov/scripts/cder/ob/resuItSJJroductcfm ?App|_Type=N&Appl_N o=201023
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`JANSSEN EXHIBIT 2108
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`Wockhardt v. Janssen lPR2016-01582
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`JANSSEN EXHIBIT 2108
`Wockhardt v. Janssen IPR2016-01582
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`