FDA Container and Carton Labels for DIFICID, NDA 201699 (NDC 52015-080-01), Fidaxomicin Tablets 200 mg

FDA Container and Carton Labels for DIFICID, NDA 201699 (NDC 52015-080-01), Fidaxomicin Tablets 200 mg

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Original Request: Hi, We are in the process of creating generic labels for Fidaxomicin tablets 200 mg, the Container and Carton labels for DIFICID, NDA 201699 (NDC 52015-080-01) are not available at Drugs@FDA , request you to please provide current container and carton labels of NDA 201699. Thank you.
Tags: Pharma, NDA, 2025
  • 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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