Angina Pectoris

• 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).

• FDA approval · 2022-08-16
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for metoprolol succinate ER tablets.

• FDA approval · 2022-08-08
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved Slate Run Pharmaceuticals' generic diltiazem hydrochloride under an original ANDA.

• FDA approval · 2022-07-08
  FDA Approved: ISOSORBIDE DINITRATE — Original Application (Advagen Pharma Ltd)

  FDA approved the original application for isosorbide dinitrate, a generic anti-anginal medication, from Advagen Pharma Ltd.

• FDA approval · 2022-06-15
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA approves a generic Verapamil Hydrochloride product from Lifestar Pharma LLC under an Original Application (ANDA).

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• FDA approval · 2022-06-07
  FDA Approved: NADOLOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Nadolol submitted by Aurobindo Pharma Limited under the ANDA, approving updated labeling for…

• 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…

• 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 label_change · 2022-01-12
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) to update the labeling, submitted by Melinta Therapeutics, LLC.

• 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 label_change · 2021-09-15
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for metoprolol tartrate products from Fresenius Kabi USA, LLC.

• CLINICAL_TRIALS trial_result · 2021-08-02
  Clinical Trial Update: Evaluate the Efficacy and Safety of MUSK Pill on Coronary Microvascular Dysfunction [Phase 4]

  Phase 4 trial evaluating MUSK Pill for coronary microvascular dysfunction with angina-related conditions; efficacy and safety data are curre…

• 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…