Atrial Flutter

• FDA approval · 2024-09-11
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals)

  FDA approved the original application for Amiodarone hydrochloride (Slate Run Pharmaceuticals) as a generic antiarrhythmic agent.

• FDA approval · 2024-09-09
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride (Hospira, Inc.), confirming it as an approved generic drug under an ANDA…

• FDA approval · 2024-08-21
  FDA Approved: DIGOXIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Digoxin submitted by Aurobindo Pharma Limited.

• FDA approval · 2024-07-16
  FDA Approved: MATZIM LA — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for MATZIM LA (diltiazem hydrochloride) from Actavis Pharma, Inc.

• FDA approval · 2024-06-20
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Lanoxin (digoxin) submitted by Covis Pharma US, Inc.

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• FDA approval · 2024-05-15
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for sotalol hydrochloride (generic). This action authorizes changes to the previously approved …

• FDA approval · 2024-04-30
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for sotalol hydrochloride from Aurobindo Pharma Limited, authorizing the generic product's approval.

• FDA approval · 2024-04-30
  FDA Approved: DOFETILIDE 0.125MG — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for dofetilide 0.125 mg (granules) by Granules Pharmaceuticals Inc., expanding the product's availab…

• FDA approval · 2024-04-29
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2024-04-23
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (FRESENIUS KABI USA, LLC)

  FDA approved the original application for Verapamil hydrochloride as a generic drug, manufactured by Fresenius Kabi USA, LLC. Verapamil hydr…

• FDA approval · 2024-04-01
  FDA Approved: IBUTILIDE FUMARATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original ANDA for ibutilide fumarate (generic) from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

• FDA approval · 2024-01-12
  FDA Approved: SOTYLIZE — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for SOTYLIZE (sotalol hydrochloride) from Azurity Pharmaceuticals, Inc.

• FDA approval · 2023-10-23
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for MULTAQ (dronedarone) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2023-09-12
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for sotalol hydrochloride from Oxford Pharmaceuticals, LLC under an ANDA.

• FDA approval · 2023-09-11
  FDA 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…

• FDA approval · 2023-06-15
  FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)

  The FDA approved a supplemental application for BETAPACE (sotalol hydrochloride) from Legacy Pharma USA, Inc.

• FDA approval · 2023-03-07
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved Slate Run Pharmaceuticals, LLC's generic diltiazem hydrochloride through an original ANDA.

• FDA approval · 2023-03-01
  FDA 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.

• FDA approval · 2023-02-28
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for Sotalol hydrochloride from Oxford Pharmaceuticals, LLC.

• FDA approval · 2023-02-21
  FDA 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…

• FDA approval · 2022-12-13
  FDA Approved: ESMOLOL HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' Esmolol hydrochloride in sodium chloride as a generic injectable under an Original Application (ANDA).

• FDA approval · 2022-12-02
  FDA 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.

• FDA approval · 2022-11-28
  FDA 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.

• FDA approval · 2022-10-25
  FDA 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…

• FDA approval · 2022-09-23
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (ScieGen Pharmaceuticals, Inc)

  FDA approves ScieGen's generic diltiazem hydrochloride under an Original Application (ANDA).