Deep Vein Thrombosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-11-30FDA Approved: HEPARIN SODIUM — Original Application (Mylan Institutional LLC)
FDA approved an Original Application for HEPARIN SODIUM (generic) from Mylan Institutional LLC, authorizing marketing of this anticoagulant.…
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FDA approval · 2017-09-29FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) by Daiichi Sankyo Inc., resulting in updated labeling.
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FDA approval · 2016-09-15FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
The FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) from Daiichi Sankyo Inc., expanding the drug's regulatory status…
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FDA approval · 2016-04-25FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
The FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) submitted by Daiichi Sankyo to modify the label, reflecting upda…
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FDA approval · 2016-02-18FDA Approved: FONDAPARINUX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for fondaparinux sodium from Dr. Reddy's Laboratories Limited, enabling a new generic version of the…
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FDA approval · 2015-11-13FDA Approved: HEPARIN SODIUM — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Heparin Sodium submitted by Fresenius Kabi USA, LLC (NDA 017651). The approval updates labeling …
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FDA approval · 2015-10-26FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for XARELTO (rivaroxaban) submitted by Janssen Pharmaceuticals, Inc.
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FDA approval · 2015-09-10FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)
The FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) submitted by Boehringer Ingelheim Pharmaceuticals, I…
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FDA approval · 2015-08-24FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for ENOXAPARIN SODIUM submitted by Sanofi-Aventis U.S. LLC.
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FDA approval · 2015-08-18FDA Approved: HEPARIN SODIUM IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved Baxter's Supplemental Application for Heparin Sodium in Sodium Chloride (Heparin Sodium), approving changes to an already-appro…
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FDA approval · 2015-01-15FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)
The FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) submitted by Boehringer Ingelheim Pharmaceuticals In…
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FDA approval · 2014-06-23FDA Approved: ENOXAPARIN SODIUM — Original Application (Italfarmaco SpA)
FDA approved the original application for ENOXAPARIN SODIUM (enoxaparin sodium) submitted by Italfarmaco SpA under an ANDA. The approval con…
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FDA approval · 2014-06-12FDA Approved: HEPARIN SODIUM — Original Application (Sandoz Inc.)
FDA approved Sandoz Inc.'s original application for generic heparin sodium, an injectable anticoagulant used to prevent and treat thrombotic…
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FDA approval · 2014-05-29FDA Approved: HEPARIN SODIUM — Supplemental Application (Hospira, Inc.)
FDA approved a supplemental application for Heparin Sodium (Hospira, Inc.), updating the approved generic product under the ANDA program.
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FDA approval · 2014-03-19FDA Approved: FONDAPARINUX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental ANDA for Fondaparinux sodium from Dr. Reddy's Laboratories Limited, authorizing the generic product to be market…
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FDA approval · 2014-03-06FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for XARELTO (rivaroxaban) submitted by Janssen Pharmaceuticals, Inc. This action approves changes re…
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FDA approval · 2013-11-15FDA Approved: ARIXTRA — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for ARIXTRA (fondaparinux sodium) submitted by Mylan Institutional LLC.
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FDA approval · 2013-10-22FDA Approved: FRAGMIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA page indicates Pfizer's supplemental application for FRAGMIN (dalteparin sodium) under NDA 020287 is under consideration for a supplemen…
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FDA approval · 2013-09-12FDA Approved: ARIXTRA — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for ARIXTRA (fondaparinux sodium) submitted by Mylan Institutional LLC.
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FDA approval · 2013-06-05FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for enoxaparin sodium (Lovenox) from Sanofi-Aventis U.S. LLC.
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FDA approval · 2013-05-20FDA Approved: HEPARIN SODIUM — Supplemental Application (Hospira, Inc.)
FDA approved a supplemental application for Hospira's heparin sodium, indicating a modification to the product's approval (likely labeling o…
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FDA approval · 2013-01-10FDA Approved: HEPARIN SODIUM IN SODIUM CHLORIDE — Supplemental Application (B. Braun Medical Inc.)
FDA approves a supplemental application for HEPARIN SODIUM IN SODIUM CHLORIDE from B. Braun Medical Inc., expanding its labeling for anticoa…
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FDA approval · 2012-12-19FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)
FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) from Boehringer Ingelheim Pharmaceuticals Inc., to modif…
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FDA approval · 2012-11-02FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for XARELTO (rivaroxaban) filed by Janssen Pharmaceuticals, Inc.
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FDA approval · 2012-03-27FDA Approved: JANTOVEN — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for Jantoven (warfarin sodium) submitted by Upsher-Smith Laboratories.