Αποτελέσματα Αναζήτησης
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 ...
DATING PERIOD. Based on the stability data submitted to date, the expiry dating period for Legubeti (acetylcysteine) for oral solution shall be 24 months from the date of manufacture when...
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.
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...
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
Exanta FDA Approval Status. 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 ...
We acknowledge receipt of your major amendments dated April 28, May 8, 12, and 24, 2023, which extended the goal date by three months. This NDA provides for the use of Exxua (gepirone)...
