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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.
Current Draft Version: December 2021. Cover letter attachment templates provided for controlled correspondences, originals, amendments, and supplements. Modify the cover letter attachment to...
5 Ιουν 2023 · This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover ...
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 ...
SUPPLEMENT APPROVAL. Please refer to your supplemental new drug applications (sNDAs) dated and received May 31, 2023, and your amendments, submitted pursuant to section 505(b)(2) of the Federal...
You must submit the patent information required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as applicable, to FDA on Form FDA 3542 within 30 days after the date...
2 Μαρ 2023 · CDER Drug and Biologic Approvals for Calendar Year 2022. CDER Drug and Biologic Approvals for Calendar Year 2021. CDER Drug and Biologic Approvals for Calendar Year 2020. CDER Drug and Biologic ...
