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  1. www.fda.gov › media › 76797PORTABLE DOCUMENT FORMAT (PDF) SPECIFICATIONS

    PDF versions 1.4 through 1.7, PDF/A-1 and PDF/A-2 are acceptable for documents. Submitted PDF files should be readable by Adobe Acrobat X, should not require additional software or...

  2. www.fda.gov › about-fda › reports-manuals-formsForms | FDA - U.S. Food and Drug Administration

    Depending on the browser you are using, you may need to download the form to enable field fillable functionality. Use the following instructions to download the form if you encounter an...

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

    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 ...

  4. www.fda.gov › media › 183338FORM FDA 3926 - U.S. Food and Drug Administration

    Form Approved: OMB No. 0910-0814 Expiration Date: June 30, 2025. See PRA Statement on last page. FORM FDA 3926 (7/22) Page 1 of 3. PSC Publishing Services (301) 443-6740 . EF. Select this box if ...

  5. en.wikipedia.org › wiki › XimelagatranXimelagatran - Wikipedia

    Ximelagatran (Exanta or Exarta, H 376/95) is an anticoagulant that has been investigated extensively as a replacement for warfarin [1] that would overcome the problematic dietary, drug interaction, and monitoring issues associated with warfarin therapy.

  6. www.bmj.com › content › 362How to use FDA drug approval documents for evidence syntheses

    10 Ιουλ 2018 · We have used FDA approval documents in meta-epidemiological projects, including an ongoing analysis of 92 anticancer agents approved by the FDA between 2000 and 2016. Here, we share our knowledge and describe how we navigate such documents efficiently.

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

    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...