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1. www.fda.gov › safety › recallsRecalls, Market Withdrawals, & Safety Alerts | FDA

   www.fda.gov › safety › recalls

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   1 Οκτ 2024 · Recalls, Market Withdrawals, & Safety Alerts. The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not...

   • Enforcement Reports

     FDA considers a recall to be a firm's removal or correction...

   • Industry Guidance For Recalls

     Public Warning and Notification of Recalls Under 21 CFR Part...

   • Major Product Recalls

     Recalls associated with Almark’s recall of hard-boiled egg...

   • Archive for Recalls, Market Withdrawals & Safety Alerts

     The Recalls, Market Withdrawals & Safety Alerts are...

2. www.fda.gov › drugs › drug-safety-and-availabilityDrug Recalls | FDA - U.S. Food and Drug Administration

   www.fda.gov › drugs › drug-safety-and-availability

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   FDA provides a searchable list of recalled products. Drug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm's own initiative, by FDA...

3. www.fda.gov › medical-devices › device-registration-and-listingSearch Registration and Listing | FDA

   www.fda.gov › medical-devices › device-registration-and-listing

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   Search the Registration & Listing database. Establishment Registration and Medical Device Listing Files for Download. Releasable establishment registration and listing information under the ...

4. www.drugs.com › history › exantaExanta (ximelagatran): What is it and is it FDA approved ... -...

   www.drugs.com › history › exanta

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   Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation.

5. s3-us-west-2.amazonaws.com › drugbank › cite_thisexanta (ximelagatran) tablets nda 21-686 fda advisory committee...

   s3-us-west-2.amazonaws.com › drugbank › cite_this

   EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 3 Development of ximelagatran The efficacy and safety of ximelagatran has been studied in a broad range of thrombogenic states in large, worldwide, comparator-controlled, and primarily outcome-based clinical studies.

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

   www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8

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   In this briefing document, AstraZeneca will provide the information necessary to make an assessment of the benefit-risk profile for ximelagatran as an oral anticoagulant and antithrombotic based on comparisons of ximelagatran to warfarin and to placebo.

7. datadashboard.fda.gov › ora › cdFDA Dashboards - Recalls - Food and Drug Administration

   datadashboard.fda.gov › ora › cd

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   Current recall data used in this Dashboard is based upon the Enforcement Reports. Only recalls classified on or after 06/08/2012 are displayed on the dashboard. For detailed information about...