Nonvalvular Atrial Fibrillation
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-10-07FDA Approved: RIVAROXABAN — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical's generic rivaroxaban under an original ANDA, for the same indications as the reference product (e.g., reduc…
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FDA approval · 2025-06-26FDA Approved: RIVAROXABAN — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' generic rivaroxaban (RIVAROXABAN) under an Original Application, enabling a generic version of the anticoa…
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FDA approval · 2025-05-15FDA Approved: RIVAROXABAN — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original application for generic rivaroxaban, a direct oral anticoagulant.
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FDA approval · 2025-05-14FDA Approved: RIVAROXABAN — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved an original application for rivaroxaban (generic) from XLCare Pharmaceuticals, Inc.
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FDA approval · 2025-05-14FDA Approved: RIVAROXABAN — Original Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' original ANDA for rivaroxaban, making a generic rivaroxaban available in the U.S. for approved indic…
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FDA approval · 2025-05-14FDA Approved: RIVAROXABAN — Original Application (Dr.Reddy's Laboratories, Inc.)
FDA approved Dr. Reddy's Laboratories' generic rivaroxaban for marketing (ANDA 208534), expanding access to the direct oral anticoagulant. T…
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FDA approval · 2025-05-14FDA Approved: RIVAROXABAN — Original Application (Macleods Pharmaceuticals Limited)
The FDA approves Macleods Pharmaceuticals Limited's original (ANDA) application for rivaroxaban, a generic version of the anticoagulant.
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FDA approval · 2025-05-14FDA Approved: RIVAROXABAN — Original Application (Changzhou Pharmaceutical Factory)
FDA approved the original application for rivaroxaban from Changzhou Pharmaceutical Factory under ANDA216995.
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FDA approval · 2025-03-03FDA Approved: RIVAROXABAN — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved the original application for rivaroxaban from Sun Pharmaceutical Industries, confirming regulatory clearance for a generic riva…
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FDA approval · 2025-02-24FDA Approved: DABIGATRAN ETEXILATE — Supplemental Application (XLCare Pharmaceuticals, Inc.)
FDA approves a supplemental application for XLCare Pharmaceuticals to market a generic dabigatran etexilate, covering its approved indicatio…
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FDA approval · 2025-02-03FDA Approved: DABIGATRAN ETEXILATE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved Mylan's original Abbreviated New Drug Application for dabigatran etexilate, enabling a generic version of this anticoagulant to…
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FDA approval · 2025-01-28FDA Approved: DABIGATRAN ETEXILATE — Original Application (Dr.Reddys Laboratories Inc)
FDA approved Dr.Reddys Laboratories Inc for a generic version of dabigatran etexilate under an Original Application, making the product avai…
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FDA approval · 2024-09-11FDA Approved: DABIGATRAN ETEXILATE — Original Application (Major Pharmaceuticals)
The FDA approved an original application for dabigatran etexilate (generic) from Major Pharmaceuticals. It covers indications such as nonval…
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FDA approval · 2024-08-16FDA Approved: DABIGATRAN ETEXILATE — Supplemental Application (Major Pharmaceuticals)
The FDA approved a supplemental application for dabigatran etexilate (generic) submitted by Major Pharmaceuticals.
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FDA approval · 2024-08-13FDA Approved: DABIGATRAN ETEXILATE — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved XLCare Pharmaceuticals' original application for dabigatran etexilate (generic), confirming a generic version of the anticoagul…
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FDA approval · 2024-08-12FDA Approved: DABIGATRAN ETEXILATE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic Pharmaceuticals' original application for dabigatran etexilate, a generic anticoagulant. It is used to reduce stroke ri…
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FDA approval · 2024-06-14FDA Approved: DABIGATRAN ETEXILATE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approves Alembic Pharmaceuticals' Original Application for dabigatan etexilate as a generic version of Pradaxa, an oral anticoagulant in…
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FDA approval · 2024-05-22FDA Approved: DABIGATRAN — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved the original ANDA (ANDA213879) for DABIGATRAN (Dabigatan etexilate), a generic anticoagulant. The approval enables Novadoz Phar…
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FDA approval · 2023-12-15FDA Approved: DABIGATRAN ETEXILATE — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original application for dabigatran etexilate as a generic anticoagulant. The generic will have the same indicat…
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FDA approval · 2023-10-18FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
FDA approves a supplemental application for SAVAYSA (edoxaban tosylate) from Daiichi Sankyo, resulting in an update to the drug’s labeling.
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FDA approval · 2021-12-20FDA Approved: XARELTO — Original Application (Janssen Pharmaceuticals, Inc.)
This FDA record documents the original approval of XARELTO (rivaroxaban) under NDA 215859, establishing its initial indication as an anticoa…
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FDA approval · 2021-06-21FDA Approved: PRADAXA — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)
FDA approved the original application for Pradaxa (dabigatran etexilate) from Boehringer Ingelheim, marking the initial NDA approval for thi…
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FDA approval · 2020-05-06FDA Approved: DABIGATRAN ETEXILATE — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved the original application for a generic dabigatran etexilate (ANDA 207961) from XLCare Pharmaceuticals, confirming the generic’s…
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FDA approval · 2020-04-21FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) submitted by Daiichi Sankyo Inc., likely updating labeling and/or in…
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FDA approval · 2020-03-11FDA Approved: DABIGATRAN ETEXILATE — Original Application (Major Pharmaceuticals)
FDA approved the original application for dabigatran etexilate from Major Pharmaceuticals, approving a generic version of the anticoagulant …