federal_register: 2023-26363

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2023-26363 Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Injection (New Drug Application 209817) Notice The Food and Drug Administration (FDA, the Agency, or we) has determined the regulatory review period for Nuzyra Injection (new drug application (NDA) 209817) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. 2023-11-30 2023 11 https://www.federalregister.gov/documents/2023/11/30/2023-26363/determination-of-regulatory-review-period-for-purposes-of-patent-extension-nuzyra-injection-new-drug https://www.govinfo.gov/content/pkg/FR-2023-11-30/pdf/2023-26363.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) has determined the regulatory review period for Nuzyra Injection (new drug application (NDA) 209817) and is publishing this notice of that determination as required by law. FDA has made the...

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