Angina Pectoris

• 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 · 2024-07-15
  FDA Approved: NADOLOL — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Nadolol from Amneal Pharmaceuticals NY LLC under ANDA 208832, confirming the continued approval …

• FDA approval · 2024-07-11
  FDA Approved: NADOLOL — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for Nadolol from Alembic Pharmaceuticals Limited, expanding access to this generic beta-blocker.

• FDA approval · 2024-07-11
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for propranolol hydrochloride by Lannett Company, Inc., approving changes to the existing ANDA to su…

• FDA approval · 2024-06-28
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for metoprolol succinate from BluePoint Laboratories to bring a generic version to market.

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• 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…

• EMA approval · 2024-04-10
  EMA Authorised: Ranexa (previously Latixa) (ranolazine) — Menarini International Operations Luxembourg S.A. (MIOL)

  The EMA authorises Ranexa (ranolazine) for angina pectoris with MIOL as the marketing author holder.

• FDA approval · 2024-03-29
  FDA Approved: ATENOLOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Atenolol by Aurobindo Pharma Limited, granting approval of a generic version under the ANDA proc…

• FDA approval · 2024-03-28
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application from Zydus Lifesciences Limited for Atenolol under ANDA 076900. This confirms approval of a gene…

• FDA approval · 2024-03-28
  FDA Approved: ATENOLOL — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for atenolol from Unichem Pharmaceuticals USA, Inc., granting an additional approval related to the …

• FDA approval · 2024-03-28
  FDA Approved: ATENOLOL — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for Atenolol by Ipca Laboratories Limited.

• FDA approval · 2024-03-01
  FDA Approved: NADOLOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Nadolol from Aurobindo Pharma Limited under ANDA201893.

• FDA approval · 2024-02-20
  FDA Approved: NITROGLYCERIN — Supplemental Application (Advagen Pharma Ltd)

  The FDA approved a supplemental application for nitroglycerin from Advagen Pharma Ltd under an ANDA, enabling marketing of the generic produ…

• FDA approval · 2024-02-16
  FDA Approved: NITROGLYCERIN — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approves Cosette Pharmaceuticals' generic nitroglycerin under an original ANDA.

• FDA approval · 2024-02-05
  FDA Approved: NADOLOL — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Nadolol submitted by Zydus Pharmaceuticals USA Inc., resulting in updated labeling and/or indica…

• FDA approval · 2024-01-18
  FDA Approved: BISOPROLOL FUMARATE — Original Application (Harman Finochem Limited)

  FDA approved Harman Finochem Limited's bisoprolol fumarate as an original generic application (ANDA). Bisoprolol fumarate is a beta-blocker …

• FDA approval · 2023-12-22
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approves a supplemental application for Tenormin (atenolol) filed by Almatica Pharma LLC.

• FDA approval · 2023-12-05
  FDA Approved: NITROGLYCERIN — Original Application (Lifestar Pharma LLC)

  FDA approved an original application for nitroglycerin from Lifestar Pharma LLC, enabling a generic nitroglycerin product.

• FDA approval · 2023-11-22
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited. The action confirms approval of changes to an…

• FDA approval · 2023-11-07
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc. The action confirms regulato…

• FDA approval · 2023-10-26
  FDA Approved: NITROGLYCERIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for nitroglycerin by Aurobindo Pharma Limited, a generic version of the drug.

• FDA approval · 2023-09-26
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for metoprolol succinate from Nivagen Pharmaceuticals, Inc., authorizing changes to the product'…

• FDA approval · 2023-08-07
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Granules India Ltd)

  FDA approved METOPROLOL SUCCINATE (extended-release) as an original generic application from Granules India Ltd, enabling its marketing for …

• FDA approval · 2023-07-25
  FDA Approved: RANOLAZINE — Original Application (Zameer Pharmaceuticals LLC)

  FDA approves the original application for ranolazine from Zameer Pharmaceuticals LLC (ANDA213085), a generic antianginal drug.

• FDA approval · 2023-07-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Burel Pharmaceuticals, LLC)

  FDA approved the original application for NICARDIPINE HYDROCHLORIDE filed by Burel Pharmaceuticals, LLC, authorizing a generic version of ni…