Angina Pectoris

• FDA approval · 2015-01-27
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for amlodipine besylate, confirming the approval and availability of Epic Pharma, LLC's generic prod…

• FDA approval · 2015-01-23
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for nitroglycerin submitted by Prasco Laboratories under the existing NDA.

• FDA approval · 2015-01-22
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Propranolol Hydrochloride from Amneal Pharmaceuticals NY LLC, indicating approval for this gener…

• FDA approval · 2015-01-11
  FDA Approved: NIFEDIPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for nifedipine from Chartwell RX, LLC.

• FDA approval · 2015-01-09
  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.

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• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental ANDA for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC, authorizing a new generic propranolol hydro…

• FDA approval · 2014-12-02
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application to add Cardene IV, an intravenous form of nicardipine hydrochloride by Baxter, for use in hospitaliz…

• FDA approval · 2014-11-21
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for AMLODIPINE BESYLATE submitted by Zydus Pharmaceuticals USA Inc. under ANDA 078226.

• FDA approval · 2014-11-07
  FDA Approved: ATENOLOL — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for Atenolol from Ipca Laboratories Limited under an ANDA.

• FDA approval · 2014-10-31
  FDA Approved: ISOSORBIDE MONONITRATE — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  The FDA approved a supplemental application for Isosorbide Mononitrate from Edenbridge Pharmaceuticals LLC., confirming approval of a generi…

• FDA approval · 2014-10-30
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2014-10-28
  FDA Approved: METOPROLOL TARTRATE — Original Application (TRUPHARMA LLC)

  FDA approved TRUPHARMA LLC's original ANDA for metoprolol tartrate, enabling a generic version of this beta-blocker. The approval makes meto…

• FDA approval · 2014-10-02
  FDA Approved: ISOSORBIDE MONONITRATE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Isosorbide Mononitrate submitted by Lannett Company, Inc.

• FDA approval · 2014-10-02
  FDA Approved: NITROGLYCERIN TRANSDERMAL INFUSION SYSTEM — Supplemental Application (Dr. Reddy's Laboratories, Inc.)

  FDA approved a supplemental application for the Nitroglycerin Transdermal Infusion System by Dr. Reddy's Laboratories, Inc. This action rela…

• FDA approval · 2014-09-26
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for amlodipine besylate submitted by Aurobindo Pharma Limited.

• FDA approval · 2014-09-26
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for amlodipine besylate, authorizing changes to an existing product's approval.

• FDA approval · 2014-09-21
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approves Ascend Laboratories' supplemental application for amlodipine besylate (a generic calcium channel blocker) as an additional appr…

• FDA approval · 2014-08-27
  FDA Approved: METOPROLOL TARTRATE — Original Application (Almaject, Inc.)

  FDA approved Almaject, Inc.'s metoprolol tartrate as an original Abbreviated New Drug Application (ANDA), establishing a generic version of …

• FDA approval · 2014-07-28
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Norvasc (amlodipine besylate) submitted by Viatris Specialty LLC.

• FDA approval · 2014-07-19
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate filed by Aurobindo Pharma Limited.

• FDA approval · 2014-04-30
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Cardene IV (nicardipine hydrochloride) submitted by Baxter Healthcare Corporation.

• FDA approval · 2014-04-03
  FDA Approved: NIFEDIPINE — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories' original ANDA for a generic nifedipine product.

• FDA approval · 2014-03-07
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Nitrostat (nitroglycerin) from Viatris Specialty LLC.

• FDA approval · 2014-01-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for METOPROLOL SUCCINATE submitted by Quallent Pharmaceuticals Health LLC.