Vasospastic Angina

• FDA approval · 2026-04-10
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for diltiazem hydrochloride from ScieGen Pharmaceuticals, Inc.

• FDA approval · 2025-11-14
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves the original application for diltiazem hydrochloride (Alembic Pharmaceuticals Limited), a generic product, for use in treating …

• FDA approval · 2024-10-18
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic diltiazem hydrochloride under an Original Application (ANDA).

• FDA approval · 2022-10-06
  FDA Approved: NIFEDIPINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for nifedipine from Ascend Laboratories, LLC, updating the existing nifedipine product.

• FDA approval · 2022-05-05
  FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE — Original Application (Dr. Reddy's Labratories Inc.)

  FDA approves Dr. Reddy's Laboratories' generic diltiazem hydrochloride extended-release tablet (ANDA 215775).

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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 · 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 · 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 · 2018-06-29
  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…

• 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…

• FDA approval · 2018-04-23
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for amlodipine besylate from Exelan Pharmaceuticals, Inc., approving a generic product.

• FDA approval · 2018-03-14
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's supplemental application for amlodipine besylate, enabling the marketing of a generic version of the antihypertensive/an…

• FDA approval · 2017-08-08
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved Zydus Pharmaceuticals USA's original application for diltiazem hydrochloride as a generic product, enabling its use for the man…

• FDA approval · 2017-03-30
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

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

• 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 · 2016-11-18
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  FDA approved a supplemental application for verapamil hydrochloride from Wilshire Pharmaceuticals, Inc., updating the existing NDA.

• 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 · 2016-01-28
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for amlodipine besylate from Cipla USA Inc.

• 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 · 2015-11-24
  FDA Approved: NIFEDIPINE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for nifedipine by Upsher-Smith Laboratories, LLC, facilitating a labeling/strength update for the ge…

• 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…