federal_register: E7-10089

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E7-10089 Determination of Regulatory Review Periods for Purposes of Patent Extension; SPRYCEL-New Drug Applications 21-986 and 22-072 Notice The Food and Drug Administration (FDA) has determined the regulatory review period for SPRYCEL--new drug applications (NDAs) 21- 986 and 22-072 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. 2007-05-25 2007 5 https://www.federalregister.gov/documents/2007/05/25/E7-10089/determination-of-regulatory-review-periods-for-purposes-of-patent-extension-sprycel-new-drug https://www.govinfo.gov/content/pkg/FR-2007-05-25/pdf/E7-10089.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined the regulatory review period for SPRYCEL--new drug applications (NDAs) 21- 986 and 22-072 and is publishing this notice of that determination as required by law. FDA has made the determination...

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