Atrial Flutter

• FDA approval · 2026-04-10
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for diltiazem hydrochloride from ScieGen Pharmaceuticals, Inc.

• FDA approval · 2026-02-27
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original abbreviated new drug application for diltiazem hydrochloride from Macleods Pharmaceuticals Limited.

• FDA approval · 2026-02-23
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  The FDA approved a supplemental application for diltiazem hydrochloride from Zydus Pharmaceuticals USA Inc., approving a generic product.

• FDA approval · 2026-02-09
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Digoxin submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2026-01-18
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Slate Run Pharmaceuticals, LLC)

  FDA approved a supplemental application for a generic diltiazem hydrochloride product from Slate Run Pharmaceuticals, LLC under an ANDA.

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• FDA approval · 2025-11-14
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves the original application for diltiazem hydrochloride (Alembic Pharmaceuticals Limited), a generic product, for use in treating …

• FDA approval · 2025-10-09
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved Covis Pharma US, Inc.'s supplemental application for LANOXIN (digoxin), authorizing changes to the product as part of an ap…

• FDA approval · 2025-09-19
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for verapamil hydrochloride from Amneal Pharmaceuticals LLC under ANDA210994. This approval authoriz…

• FDA approval · 2025-09-11
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for diltiazem hydrochloride from Actavis Pharma, Inc., confirming/expanding the product's regulatory…

• FDA approval · 2025-08-08
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for Diltiazem Hydrochloride by Alembic Pharmaceuticals Inc. The action represents a supplemental reg…

• FDA approval · 2025-07-23
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (ALTATHERA Pharmaceuticals, LLC)

  FDA approved a supplemental application for sotalol hydrochloride from ALTATHERA Pharmaceuticals, indicating an update to its labeling and/o…

• FDA approval · 2025-07-10
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for diltiazem hydrochloride (generic) from Sun Pharmaceutical Industries, Inc. under an ANDA. This a…

• FDA approval · 2025-07-02
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a generic diltiazem hydrochloride product from Ingenus Pharmaceuticals under an Original Application (ANDA), expanding access t…

• FDA approval · 2025-05-06
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for diltiazem hydrochloride from Mylan Pharmaceuticals Inc., enabling continued marketing of the…

• FDA approval · 2025-04-16
  FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved Oceanside Pharmaceuticals' supplemental NDA for the extended-release form of diltiazem hydrochloride.

• FDA approval · 2025-04-16
  FDA Approved: CARDIZEM LA — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for Cardizem LA (diltiazem hydrochloride extended-release) submitted by Bausch Health US LLC.

• FDA approval · 2025-04-16
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for diltiazem hydrochloride by Oceanside Pharmaceuticals.

• FDA approval · 2025-04-14
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for Digoxin submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2025-02-24
  FDA Approved: DOFETILIDE — Supplemental Application (Dr. Reddy's Labratories Inc.)

  FDA approved a supplemental application for the generic DOFETILIDE from Dr. Reddy's Labratories Inc., authorizing the generic product.

• FDA approval · 2025-02-21
  FDA Approved: DILTIAZEM HYDROCHLORIDE IN SODIUM CHLORIDE — Original Application (WG Critical Care, LLC)

  FDA approved a new injectable diltiazem hydrochloride in sodium chloride under an original NDA from WG Critical Care, LLC. This parenteral f…

• FDA approval · 2025-02-04
  FDA Approved: PROCAINAMIDE HYDROCHLORIDE — Original Application (Caplin Steriles Limited)

  FDA approved Caplin Steriles Limited's original ANDA for Procainamide hydrochloride, a generic antiarrhythmic drug.

• FDA approval · 2024-11-19
  FDA Approved: DIGOXIN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals, Inc.'s supplemental application for Digoxin, granting regulatory approval for an update to an already …

• FDA approval · 2024-10-18
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic diltiazem hydrochloride under an Original Application (ANDA).

• FDA approval · 2024-10-17
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for Propafenone Hydrochloride filed by Strides Pharma Science Limited, adding a approved generic…

• FDA approval · 2024-09-12
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for diltiazem hydrochloride by Mylan Pharmaceuticals Inc. under ANDA074910, indicating regulatory ap…