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

   www.fda.gov › media › 183338

   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 ...

2. 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

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

   www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8

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   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 ...

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

   www.fda.gov › about-fda › reports-manuals-forms

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   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...

5. 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...

6. www.fda.gov › drugs › development-approval-process-drugsForms & Submission Requirements - FDA

   www.fda.gov › drugs › development-approval-process-drugs

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   15 Φεβ 2022 · Forms. Official FDA applications and submissions forms. Electronic Regulatory Submission and Review. Information about review and electronic submission of regulatory information

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

   en.wikipedia.org › wiki › Ximelagatran

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   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.