Stable Angina

• FDA approval · 2023-05-09
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for a generic Metoprolol Succinate product from Quallent Pharmaceuticals Health LLC.

• 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 · 2018-06-18
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  The FDA approved the original application for Verapamil Hydrochloride by Somerset Therapeutics, LLC, enabling a generic version of verapamil…

• FDA approval · 2018-05-21
  FDA Approved: NIFEDIPINE — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for nifedipine submitted by Leading Pharma, LLC.

• FDA approval · 2018-04-26
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for amlodipine besylate submitted by Unichem Pharmaceuticals (USA), Inc., under ANDA 203245. This co…

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• FDA approval · 2017-01-23
  FDA Approved: CARDIZEM CD — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for Cardizem CD (diltiazem hydrochloride) from Bausch Health US LLC under NDA 020062, allowing c…

• FDA approval · 2017-01-04
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for amlodipine besylate from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2016-07-11
  FDA Approved: AMLODIPINE BESYLATE — Original Application (POLYGEN PHARMACEUTICALS INC.)

  FDA approved the original application for amlodipine besylate by Polygen Pharmaceuticals Inc., broadening access to a generic calcium channe…

• FDA approval · 2016-01-19
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for amlodipine besylate from Unichem Pharmaceuticals (USA), Inc. to bring a generic product to marke…

• FDA approval · 2015-12-21
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for amlodipine besylate from Cipla USA Inc., effectively approving a generic formulation of amlodipi…

• FDA approval · 2015-12-10
  FDA Approved: AMLODIPINE BESYLATE — Original Application (Exelan Pharmaceuticals, Inc.)

  FDA approves the Original Application for amlodipine besylate, a generic version of the calcium channel blocker used to treat hypertension a…

• FDA approval · 2015-10-19
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Epic Pharma, LLC)

  The FDA approved Epic Pharma, LLC's supplemental application for amlodipine besylate, enabling a generic version of amlodipine besylate to b…

• FDA approval · 2015-09-25
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (PD-Rx Pharmaceuticals, Inc.)

  FDA approved a supplemental application for amlodipine besylate by PD-Rx Pharmaceuticals, Inc. under ANDA 076719, allowing marketing of this…

• FDA approval · 2015-09-17
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for AMLODIPINE BESYLATE from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2014-06-05
  FDA Approved: PROCARDIA XL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Procardia XL (nifedipine) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2013-12-12
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Plavix (clopidogrel) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2013-08-26
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved the supplemental application for amlodipine besylate from Lupin Pharmaceuticals, making its generic calcium channel blocker ava…

• FDA approval · 2012-08-01
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved metoprolol succinate as a generic product through an original ANDA submission by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2011-11-29
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Verapamil Hydrochloride from Chartwell RX, LLC.

• FDA approval · 2011-09-27
  FDA Approved: PROCARDIA XL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for PROCARDIA XL (nifedipine) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2011-04-21
  FDA Approved: MATZIM LA — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for MATZIM LA (diltiazem hydrochloride) by Actavis Pharma, Inc.

• FDA approval · 2010-04-09
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' supplemental application for amlodipine besylate (generic). This action confirms the continued availabili…

• FDA approval · 2009-05-04
  FDA Approved: AMLODIPINE BESYLATE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original application for amlodipine besylate, a generic version, for indications including hypertens…

• FDA approval · 2008-07-17
  FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Diltiazem Hydrochloride Extended-Release from Endo USA, Inc., resulting in an approved update to…

• FDA approval · 2007-07-17
  FDA Approved: AMLODIPINE BESYLATE — Original Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma's amlodipine besylate as a generic product. It is indicated for hypertension and various forms of angina.