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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
19 Αυγ 2020 · The FDA Orange Book, or Approved Drug Products with Therapeutic Equivalence Evaluations, is the definitive source to link drugs with the patents that protect them.
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 ...
11 Οκτ 2024 · Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number. Jump to: Orange Book Publications ...
8 Μαρ 2023 · Downloadable Data Files for the Orange Book. The compressed (.ZIP) data file unzips into three files, whose field descriptions appear below. All three files are in ASCII text, tilde (~)...
Ximelagatran is the first oral treatment in a new World Health Organization class of direct thrombin inhibitors and is the first new oral anticoagulant since the introduction of warfarin almost 60 years ago ( ). It was submitted to the Food and Drug Administration (FDA) for approval in December 2003 ( ).
Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
