XARELTO

FDA-2024-P-0526 · 10 docket documents

Lupin, Inc. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Apixaban Oral Suspension, 1.25 mg/mL suitable for consideration in an ANDA, with the reference drug product being ELIQUIS (apixaban) Tablets by Bri

FDA-2019-P-3022 · 9 docket documents

Foley & Lardner LLP filed this citizen petition under 21 CFR § 314.93 and Section 505(j)(2)(C) requesting that the FDA declare rivaroxaban capsules in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg suitable for submission as an ANDA, with XARELTO (rivaroxaban) tablets of the same strengths as the refe

FDA-2015-P-3408 · 5 docket documents

David Cundiff filed this citizen petition under 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA designate all anticoagulants including heparin, low molecular weight heparins, fondaparinux, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban as contraindicated for patien

FDA-2015-P-3410 · 4 docket documents

David K. Cundiff filed this petition under the Federal Food, Drug, and Cosmetic Act section 355(e)(3) on September 25, 2015, requesting that the FDA withdraw approval and designate all oral anticoagulants including warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban as contraindicated for non-

FDA-2015-P-2373 · 4 docket documents

David K. Cundiff, MD filed this petition under 21 U.S.C. Section 355(e)(3) requesting that the FDA revoke approval and add contraindication labels for all anticoagulant drugs including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban for the treatment of venous thromboembolism (dee