Coronary Artery Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-02-08FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.
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FDA approval · 2023-12-05FDA Approved: NITROGLYCERIN — Original Application (Lifestar Pharma LLC)
FDA approved an original application for nitroglycerin from Lifestar Pharma LLC, enabling a generic nitroglycerin product.
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FDA approval · 2023-11-21FDA Approved: BIVALIRUDIN — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for bivalirudin from Dr. Reddy's Laboratories Limited, indicating an approved change to an exist…
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FDA approval · 2023-09-12FDA Approved: ATORVASTATIN CALCIUM — Original Application (NorthStar RxLLC)
FDA approved the Original Application for atorvastatin calcium from NorthStar RxLLC, enabling a generic atorvastatin calcium product to ente…
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FDA approval · 2023-09-08FDA Approved: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved a supplemental application for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (Baxter).
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FDA approval · 2023-08-22FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, authorizing a generi…
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FDA approval · 2023-08-09FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
FDA approved a Supplemental Application for ZOCOR (simvastatin) submitted by Organon LLC.
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FDA approval · 2023-06-08FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)
FDA approves a supplemental application for a generic clopidogrel product from Aurobindo Pharma Limited.
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FDA approval · 2023-06-06FDA Approved: NITROGLYCERIN — Supplemental Application (Dr. Reddys Laboratories Inc)
FDA approved a supplemental application for nitroglycerin submitted by Dr. Reddys Laboratories Inc.
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FDA approval · 2023-05-23FDA Approved: REGADENOSON — Original Application (Baxter Healthcare Corporation)
FDA approved Regadenoson (REGADENOSON) as a pharmacologic stress agent for myocardial perfusion imaging in adults unable to perform exercise…
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FDA approval · 2023-05-12FDA Approved: AMMONIA N 13 — Supplemental Application (SOFIE Co. dba SOFIE)
FDA approved a supplemental application for Ammonia N-13 (AMMONIA N-13) from SOFIE Co. dba SOFIE, updating its regulatory approval. This app…
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FDA approval · 2023-04-25FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Limited.
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FDA approval · 2023-04-21FDA Approved: TICAGRELOR — Original Application (Ascend Laboratories, LLC)
FDA approved Ticagrelor under an Original Application by Ascend Laboratories, LLC. The approval supports its use as an antiplatelet therapy …
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FDA approval · 2023-04-12FDA Approved: PRASUGREL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for the generic prasugrel from Accord Healthcare Inc., finalizing a regulatory action under the ANDA…
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FDA approval · 2023-04-04FDA Approved: REGADENOSON — Original Application (Mylan Institutional LLC)
FDA approved the original ANDA for Regadenoson from Mylan Institutional LLC, enabling a generic version of the vasodilator used in pharmacol…
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FDA approval · 2023-03-20FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Pravastatin Sodium from Aurobindo Pharma Limited, confirming continued approval of this generic …
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FDA approval · 2023-03-08FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s supplemental application for atorvastatin calcium (generic atorvastatin calcium) under an ANDA.
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FDA approval · 2023-02-02FDA Approved: REGADENOSON — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approves Hikma Pharmaceuticals USA Inc. for Regadenoson (ANDA 215827) as a generic injectable pharmacologic stress agent for myocardial …
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FDA approval · 2022-12-16FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for the fixed-dose combination of ezetimibe and simvastatin from Ascend Laboratories, LLC.
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FDA approval · 2022-12-06FDA Approved: MYOVIEW — Supplemental Application (Medi-Physics Inc. dba GE Healthcare)
FDA approved a supplemental application for MYOVIEW (tetrofosmin) submitted by Medi-Physics Inc. dba GE Healthcare.
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FDA approval · 2022-11-07FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Aurobindo Pharma Limited)
FDA approved the original ANDA for Isosorbide Mononitrate from Aurobindo Pharma Limited.
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FDA approval · 2022-11-03FDA Approved: AMMONIA N 13 — Original Application (University of Alabama at Birmingham)
FDA approved the original application for Ammonia N-13 (NH3N13), a radiopharmaceutical imaging agent developed by the University of Alabama …
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FDA approval · 2022-10-26FDA Approved: REGADENOSON — Original Application (Eugia US LLC)
FDA approved Regadenoson via an original application for Eugia US LLC (ANDA216437), enabling a generic version of Regadenoson for pharmacolo…
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FDA approval · 2022-08-31FDA Approved: REGADENOSON — Original Application (Hospira, Inc.)
FDA approved Hospira's Regadenoson as a generic (ANDA 214349) for use as a pharmacologic stress agent to detect myocardial ischemia in patie…
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FDA approval · 2022-07-12FDA Approved: REGADENOSON — Original Application (Almaject, Inc.)
The FDA approved Almaject, Inc.'s original Abbreviated New Drug Application for regadenoson, a pharmacologic stress agent used in myocardial…