Angina Pectoris

• 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.

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• 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…

• FDA approval · 2023-07-05
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lopressor (metoprolol tartrate) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2023-06-12
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved the Original Application (ANDA216916) for Metoprolol succinate, a generic version manufactured by Granules Pharmaceuticals Inc.

• FDA approval · 2023-06-06
  FDA Approved: NITROGLYCERIN — Supplemental Application (Dr. Reddys Laboratories Inc)

  FDA approved a supplemental application for nitroglycerin submitted by Dr. Reddys Laboratories Inc.

• FDA approval · 2023-05-26
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for metoprolol succinate from BluePoint Laboratories, allowing continued manufacture of the gene…

• FDA approval · 2023-05-05
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for metoprolol succinate from Zydus Pharmaceuticals (USA) Inc., approving its generic product under …

• FDA approval · 2023-05-01
  FDA Approved: NIFEDIPINE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for nifedipine from Ingenus Pharmaceuticals, LLC, for an already approved generic nifedipine product…

• FDA approval · 2023-04-14
  FDA Approved: KAPSPARGO — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for KAPSPARGO (metoprolol succinate) by Sun Pharmaceutical Industries.

• FDA approval · 2023-03-16
  FDA Approved: RANOLAZINE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves the original ANDA for ranolazine from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2023-03-10
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for Toprol XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• 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 · 2023-02-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for metoprolol succinate from Actavis Pharma, Inc., authorizing a generic extended-release metoprolo…

• FDA approval · 2023-02-06
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA approves a supplemental application for nicardipine hydrochloride (generic) submitted by Lifestar Pharma LLC.

• FDA approval · 2022-12-23
  FDA Approved: RANOLAZINE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's generic Ranolazine under an Original Application (ANDA209081).

• FDA approval · 2022-12-16
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's nicardipine hydrochloride generic under an original ANDA, enabling its marketing for indicated uses.

• FDA approval · 2022-11-18
  FDA Approved: NIFEDIPINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals Inc.'s nifedipine under an original ANDA, authorizing a generic nifedipine product.

• FDA approval · 2022-11-07
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for Isosorbide Mononitrate from Aurobindo Pharma Limited.

• FDA approval · 2022-10-06
  FDA Approved: NIFEDIPINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for nifedipine from Ascend Laboratories, LLC, updating the existing nifedipine product.

• FDA approval · 2022-09-26
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for nicardipine hydrochloride, enabling the marketing of this generic product…