Yahoo Αναζήτηση Διαδυκτίου

Αποτελέσματα Αναζήτησης

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. 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 ...

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

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

   • Αποθηκευμένο αντίγραφο

   Listing of all external Forms both OMB approved and state using ORA forms.

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.researchgate.net › publication › 344943526_New_Drug_Application_NDA(PDF) New Drug Application (NDA) - ResearchGate

   www.researchgate.net › publication › 344943526_New_Drug_Application_NDA

   21 Οκτ 2020 · PDF | A brief overview of the NDA (updated October 2020) | Find, read and cite all the research you need on ResearchGate

7. www.clinicaltrialsarena.com › projects › exantaExanta – Oral Direct Thrombin Inhibitor for the

   www.clinicaltrialsarena.com › projects › exanta

   • Αποθηκευμένο αντίγραφο

   25 Ιουν 2003 · Exanta (ximelagatran) is an oral direct thrombin inhibitor developed by AstraZeneca. It is indicated for the prevention and treatment of venous thromboembolism (VTE) and potentially for the prevention of stroke in patients with atrial fibrillation.