Angina Pectoris

• FDA approval · 2019-09-13
  FDA Approved: NADOLOL — Original Application (VGYAAN Pharmaceuticals LLC)

  The FDA approved Nadolol as a generic product through an Original Application (ANDA) from VGYAAN Pharmaceuticals LLC. Nadolol is a non-selec…

• FDA approval · 2019-08-19
  FDA Approved: RANOLAZINE — Original Application (Viona Pharmaceuticals Inc)

  FDA approves a generic version of ranolazine from Viona Pharmaceuticals Inc under an Original ANDA (ANDA210188).

• FDA approval · 2019-07-08
  FDA Approved: KATERZIA — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approves KATERZIA (amlodipine) through an Original Application by Azurity Pharmaceuticals, introducing an amlodipine oral suspension. Th…

• FDA approval · 2019-07-05
  FDA Approved: RANOLAZINE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's generic ranolazine for chronic angina as an original ANDA approval.

• FDA approval · 2019-06-14
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved Ingenus Pharmaceuticals' generic diltiazem hydrochloride via an original ANDA submission.

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• FDA approval · 2019-06-04
  FDA Approved: RANOLAZINE — Original Application (Radha Pharmaceuticals, Inc)

  FDA approved Radha Pharmaceuticals' original ANDA for ranolazine (generic ranolazine). The approval confirms a generic formulation of ranola…

• FDA approval · 2019-05-28
  FDA Approved: RANOLAZINE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma, Inc.'s original ANDA for ranolazine, a generic oral therapy for chronic angina. This approval makes a gener…

• FDA approval · 2019-05-28
  FDA Approved: RANOLAZINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for ranolazine, enabling a generic version of the anti-anginal medication.

• FDA approval · 2019-05-03
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (TRUPHARMA LLC)

  FDA approved a supplemental application for metoprolol tartrate submitted by TRUPHARMA LLC.

• FDA approval · 2019-04-30
  FDA Approved: NITROGLYCERIN — Original Application (Natco Pharma USA LLC)

  FDA has approved Natco Pharma USA LLC's Nitroglycerin generic under an Original Application (ANDA211604).

• FDA approval · 2019-04-29
  FDA Approved: FELODIPINE — Original Application (Carlsbad Technology, Inc.)

  FDA approved Felodipine through an original application filed by Carlsbad Technology, Inc., for treatment of hypertension. Felodipine is als…

• FDA approval · 2019-03-22
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's supplemental application for propranolol hydrochloride (generic propranolol HCl).

• FDA approval · 2019-03-12
  FDA Approved: NIFEDIPINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approves Ingenus Pharmaceuticals' generic nifedipine under an Original Application (ANDA210614). The approved product is indicated for h…

• FDA approval · 2018-12-28
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Armas Pharmaceuticals Inc.)

  FDA approves Armas Pharmaceuticals' verapamil hydrochloride as an original ANDA generic; standard indications for verapamil HCl include hype…

• FDA approval · 2018-12-19
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Oryza Pharmaceuticals, Inc)

  The FDA approved Oryza Pharmaceuticals' generic metoprolol succinate product, an extended-release beta-blocker used to treat hypertension, a…

• FDA approval · 2018-11-05
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals, LLC's original application for isosorbide mononitrate, a generic product indicated for the prevention …

• FDA approval · 2018-10-29
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  The FDA approved a supplemental application for metoprolol succinate submitted by Zydus Pharmaceuticals (USA) Inc., updating the labeling fo…

• FDA approval · 2018-10-26
  FDA Approved: METOPROLOL SUCCINATE — Original Application (BluePoint Laboratories)

  FDA approved a generic metoprolol succinate product from BluePoint Laboratories under an original ANDA for the treatment of hypertension, an…

• FDA approval · 2018-10-26
  FDA Approved: FELODIPINE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' felodipine extended-release tablets under an original generic application (ANDA). The product is a…

• FDA approval · 2018-08-30
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approves Upsher-Smith's generic diltiazem hydrochloride through an original ANDA (ANDA205231) for use as a calcium channel blocker.

• FDA approval · 2018-08-29
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Chartwell RX, LLC)

  FDA approved an original ANDA for isosorbide mononitrate by Chartwell RX, LLC, enabling a generic version of the drug.

• FDA approval · 2018-07-30
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Nitroglycerin submitted by Prasco Laboratories, signaling an approval-related action affecting t…

• FDA approval · 2018-07-23
  FDA Approved: NADOLOL — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved Nadolol as an original application from Unichem Pharmaceuticals (USA), Inc., establishing a generic nadolol product.

• FDA approval · 2018-07-13
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's VERAPAMIL HYDROCHLORIDE as an original ANDA generic product.

• FDA approval · 2018-06-29
  FDA Approved: NIFEDIPINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for Nifedipine from Zydus Lifesciences Limited, a generic calcium channel blocker used for hypertensio…