RIVAROXABAN | A208220 | BRECKENRIDGE PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Foley & Lardner LLP 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 | Other | 2019-06-25 | Denied | Foley & Lardner LLP |
Citizen Petition from David Cundiff 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 | Other | 2015-10-26 | Denied | David Cundiff |
Citizen Petition from David K Cundiff 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- | Other | 2015-10-07 | Denied | David K Cundiff |
Citizen Petition from David K. Cundiff, MD 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 | Other | 2015-07-14 | Denied | David K. Cundiff, MD |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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