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    FDA Container, Carton, and PI Labels for NDA 006488 Xylocaine 1% 100 mg/10mL with Preservative

    FDA Container, Carton, and PI Labels for NDA 006488 Xylocaine 1% 100 mg/10mL with Preservative

    $69.00 USD
    $69.00 USD
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    Original Request: I am requesting the most current and submitted labels for NDA 006488, Xylocaine, 1% 100 mg/10mL, container, carton, and most recent package insert containing this strength. Please note that the strength being requested is the product that contains a preservative. There are two other products approved for this NDA, Xylocaine-MPF and Xlyocaine with Epinephrine which are not part of this request. At Drugs@FDA the last time we see the product we are requesting mentioned in a PI was in Supplement-74, action date 02/19/2010 but we are unsure if this is the last PI to have it mentioned and a copy of the container and carton labels are not included. Please feel free to contact me if there is any need for further clarification.
    Tags: Pharma, NDA, 2010
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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