Angina Pectoris

• FDA approval · 2022-06-01
  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. This action updates…

• FDA approval · 2022-05-05
  FDA Approved: RANOLAZINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original ANDA for ranolazine, allowing a generic version of the antianginal medication.

• FDA approval · 2022-04-29
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Shandong New Time Pharmaceutical Co., Ltd.)

  FDA approves the original application for Isosorbide Mononitrate generic from Shandong New Time Pharmaceutical Co., Ltd.

• FDA approval · 2022-04-27
  FDA Approved: RANOLAZINE — Original Application (A2A Integrated Pharmaceuticals)

  FDA approves the original ANDA for Ranolazine submitted by A2A Integrated Pharmaceuticals.

• FDA approval · 2022-04-26
  FDA Approved: NIFEDIPINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for nifedipine from Ascend Laboratories, LLC, under the existing ANDA, authorizing changes to an…

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• FDA approval · 2022-03-29
  FDA Approved: NIFEDIPINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' Original Application for nifedipine, a calcium channel blocker used to treat hypertension and angina.

• FDA approval · 2022-03-17
  FDA 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…

• FDA approval · 2022-02-28
  FDA Approved: ASPRUZYO SPRINKLE — Original Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  The FDA approved ASPRUZYO SPRINKLE (ranolazine) from Sun Pharmaceutical Industries under an original NDA, introducing a sprinkle formulation…

• FDA approval · 2022-02-24
  FDA Approved: NORLIQVA — Original Application (CMP Pharma, Inc.)

  FDA approved NORLIQVA (amlodipine) from CMP Pharma as an original application. The product is indicated for the treatment of hypertension an…

• FDA approval · 2022-02-01
  FDA Approved: ISOSORBIDE MONONITRATE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Isosorbide Mononitrate from Lannett Company, Inc., indicating an additional labeling action for …

• FDA approval · 2022-01-26
  FDA Approved: ISOSORBIDE MONONITRATE — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for Edenbridge Pharmaceuticals' generic Isosorbide Mononitrate.

• FDA approval · 2021-12-20
  FDA 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…

• FDA approval · 2021-11-09
  FDA Approved: PROCARDIA XL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Procardia XL (nifedipine) from Pfizer Laboratories Div Pfizer Inc, updating the drug's label…

• FDA approval · 2021-11-08
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for a generic metoprolol succinate product from Epic Pharma, LLC.

• FDA approval · 2021-10-25
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for metoprolol tartrate (generic beta-blocker), under an ANDA.

• FDA approval · 2021-07-19
  FDA Approved: NIFEDIPINE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's nifedipine generic through an original ANDA, covering common indications such as hypertension and an…

• FDA approval · 2021-05-03
  FDA Approved: NITROGLYCERIN — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's generic nitroglycerin under an Original Application (ANDA 209779), enabling marketing of the generic produ…

• FDA approval · 2021-04-08
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Eugia US LLC)

  FDA approved Eugia US LLC's original ANDA for nicardipine hydrochloride as a generic product, enabling marketing of the generic once authori…

• FDA approval · 2021-03-22
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approves Glenmark's diltiazem hydrochloride as an original ANDA; the product is a generic calcium channel blocker indicated for hyperten…

• FDA approval · 2021-03-02
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride by Mylan Pharmaceuticals, signaling approval of an updated or additional…

• FDA approval · 2020-11-30
  FDA Approved: RANOLAZINE — Original Application (Ascend Laboratories, LLC)

  FDA approved the original ANDA for ranolazine (generic) from Ascend Laboratories, LLC.

• FDA approval · 2020-11-18
  FDA Approved: NIFEDIPINE — Original Application (Elite Pharmaceutical Solution, Inc.)

  FDA approved the Original Application for nifedipine from Elite Pharmaceutical Solution, Inc., approving the generic nifedipine product.

• FDA approval · 2020-11-06
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved a generic version of metoprolol succinate (Camber Pharmaceuticals) under an Original Application (ANDA 205541).

• FDA approval · 2020-10-15
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Sagent Pharmaceuticals)

  The FDA approved the original application for Verapamil hydrochloride from Sagent Pharmaceuticals, establishing a generic version of this ca…

• FDA approval · 2020-10-15
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for Verapamil hydrochloride from Zydus Pharmaceuticals USA Inc., confirming the generic formulation of…