Atrial Fibrillation
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-09-12FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)
FDA approved a supplemental application for sotalol hydrochloride from Oxford Pharmaceuticals, LLC under an ANDA.
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FDA approval · 2023-09-11FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approves Apotex Corp.'s supplemental application for sotalol hydrochloride, enabling a generic version of the antiarrhythmic for clinica…
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FDA approval · 2023-06-15FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)
The FDA approved a supplemental application for BETAPACE (sotalol hydrochloride) from Legacy Pharma USA, Inc.
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FDA approval · 2023-03-07FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved Slate Run Pharmaceuticals, LLC's generic diltiazem hydrochloride through an original ANDA.
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FDA approval · 2023-03-01FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved Upsher-Smith's generic diltiazem hydrochloride (Original Application) as a generic version of diltiazem hydrochloride.
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FDA approval · 2023-02-28FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)
FDA approved a supplemental application for Sotalol hydrochloride from Oxford Pharmaceuticals, LLC.
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FDA approval · 2023-02-21FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)
FDA approved a generic Propafenone hydrochloride product from Aurobindo Pharma Limited under an Original Application. This marks market entr…
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FDA approval · 2022-12-02FDA Approved: ESMOLOL HYDROCHLORIDE — Original Application (WG Critical Care, LLC)
FDA approved the original application for esmolol hydrochloride in saline (sodium chloride) solution, a generic injectable beta-blocker.
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FDA approval · 2022-11-28FDA Approved: DOFETILIDE — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for dofetilide filed by Bionpharma Inc. under an ANDA, approving a change to the approved product.
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FDA approval · 2022-11-02FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)
The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Covis Pharma US, Inc. This approval covers the changes reques…
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FDA approval · 2022-10-25FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for sotalol hydrochloride by Teva Pharmaceuticals USA, Inc., indicating regulatory approval of a…
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FDA approval · 2022-09-23FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (ScieGen Pharmaceuticals, Inc)
FDA approves ScieGen's generic diltiazem hydrochloride under an Original Application (ANDA).
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FDA approval · 2022-09-08FDA Approved: FLECAINIDE ACETATE — Original Application (Epic Pharma, LLC)
FDA approved the original application for flecainide acetate tablets from Epic Pharma, LLC under ANDA215599.
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FDA approval · 2022-08-23FDA Approved: WARFARIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Warfarin sodium submitted by Amneal Pharmaceuticals LLC.
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FDA approval · 2022-08-08FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved Slate Run Pharmaceuticals' generic diltiazem hydrochloride under an original ANDA.
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FDA approval · 2022-06-15FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)
FDA approves a generic Verapamil Hydrochloride product from Lifestar Pharma LLC under an Original Application (ANDA).
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FDA approval · 2022-05-05FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE — Original Application (Dr. Reddy's Labratories Inc.)
FDA approves Dr. Reddy's Laboratories' generic diltiazem hydrochloride extended-release tablet (ANDA 215775).
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FDA approval · 2022-03-21FDA Approved: ESMOLOL HYDROCHLORIDE — Original Application (Eugia US LLC)
FDA approved the original application for esmolol hydrochloride in sodium chloride injection, a generic product manufactured by Eugia US LLC…
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FDA approval · 2022-03-17FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved the original Abbreviated New Drug Application for verapamil hydrochloride from Heritage Pharmaceuticals (d/b/a Avet) as a gener…
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FDA approval · 2022-03-11FDA Approved: DIGOXIN — Original Application (Amici Pharma, Inc)
FDA approved the original ANDA for digoxin from Amici Pharma, authorizing a generic digoxin product.
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FDA approval · 2022-02-08FDA Approved: DIGOXIN — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original application for a generic digoxin product, enabling marketing in the United States.
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FDA approval · 2021-12-20FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)
The FDA approved a supplemental application for Hospira's verapamil hydrochloride under an existing approved product, marking an update to t…
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FDA approval · 2021-11-22FDA Approved: DIGOXIN — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' generic digoxin product (DIGOXIN) under an original ANDA. Digoxin is used to treat heart failure and certa…
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FDA approval · 2021-10-14FDA Approved: DOFETILIDE 0.125MG — Original Application (Granules Pharmaceuticals Inc.)
FDA approved a generic version of dofetilide (0.125 mg) from Granules Pharmaceuticals Inc., expanding access to this antiarrhythmic.
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FDA approval · 2021-06-03FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)
FDA approved a supplemental application for Betapace (sotalol hydrochloride) filed by Legacy Pharma USA, Inc.