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1. s3-us-west-2.amazonaws.com › 84280017D2DC4084B88D22698665EABAexanta (ximelagatran) tablets nda 21-686 fda advisory committee...

   s3-us-west-2.amazonaws.com › 84280017D2DC4084B88D22698665EABA

   approval for the use of EXANTA® (ximelagatran) Tablets as: œ An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute

2. www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee...

   www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8

   • Αποθηκευμένο αντίγραφο

   New Drug Application (NDA) 21-686, submitted by AstraZeneca LP (AstraZeneca), requests approval for the use of EXANTA® (ximelagatran) Tablets as: An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute VTE An oral 36-mg bid fixed dose ...

3. get.adobe.com › readerAdobe - Download Adobe Acrobat Reader

   get.adobe.com › reader

   Download free Adobe Acrobat Reader software for your Windows, Mac OS and Android devices to view, print, and comment on PDF documents.

4. www.accessdata.fda.gov › drugsatfda_docs › ndaDrug Approval Package: Prelay (Troglitazone) NDA# 020719/S012

   www.accessdata.fda.gov › drugsatfda_docs › nda

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   Note: Documents in PDF format require the Adobe Acrobat Reader®. Links on this page: Note: If you need help accessing information in different file formats, see Instructions for Downloading...

5. www.drugs.com › history › exantaExanta (ximelagatran): What is it and is it FDA approved ... -...

   www.drugs.com › history › exanta

   • Αποθηκευμένο αντίγραφο

   FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation. Exanta (ximelagatran) is an investigational oral direct thrombin inhibitor (oral DTI) intended for use in the prevention of strokes in patients with atrial fibrillation, for the prevention ...

6. www.fda.gov › media › 134964FORM FDA 3674 - U.S. Food and Drug Administration

   www.fda.gov › media › 134964

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7. www.accessdata.fda.gov › drugsatfda_docs › appletterNDA 216165 NDA APPROVAL - Food and Drug Administration

   www.accessdata.fda.gov › drugsatfda_docs › appletter

   NDA APPROVAL. Please refer to your new drug application (NDA) dated and received June 22, 2023, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and...