Angina Pectoris

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

  FDA approves Somerset Therapeutics' Verapamil hydrochloride as an original application, granting a generic version of the drug.

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

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

• FDA approval · 2018-04-26
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Epic Pharma, LLC)

  The FDA approved a supplemental application for the generic drug amlodipine besylate submitted by Epic Pharma, LLC. This represents authoriz…

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

  FDA approved a supplemental application for amlodipine besylate (generic) filed by ACI Healthcare USA, Inc., supporting continued marketing …

• 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.

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• FDA approval · 2018-04-23
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (POLYGEN PHARMACEUTICALS INC.)

  FDA approved a supplemental application for amlodipine besylate from PolyGen Pharmaceuticals, approving a generic version.

• FDA approval · 2018-04-20
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for amlodipine besylate under ANDA077073.

• FDA approval · 2018-04-02
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (PD-Rx Pharmaceuticals, Inc.)

  FDA approved a supplemental application for amlodipine besylate filed by PD-Rx Pharmaceuticals, Inc. The action concerns a supplemental appr…

• FDA approval · 2018-04-02
  FDA Approved: AMLODIPINE BESYLATE 2.5 MG — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approves a supplemental application to add a 2.5 mg strength of amlodipine besylate (generic) manufactured by Oxford Pharmaceuticals, ex…

• FDA approval · 2018-03-23
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the original application for METOPROLOL SUCCINATE (generic) from Zydus Pharmaceuticals (USA) Inc., authorizing its marketing as…

• FDA approval · 2018-03-14
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the Supplemental Application for Aurobindo Pharma Limited to market amlodipine besylate as a generic formulation.

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

  The FDA approved a supplemental application for amlodipine besylate filed by Zydus Pharmaceuticals USA Inc. The action confirms approval of …

• FDA approval · 2018-01-26
  FDA Approved: KAPSPARGO — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved KAPSPARGO (metoprolol succinate) through an original new drug application by Sun Pharmaceutical Industries, marking regulatory …

• FDA approval · 2018-01-24
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for NITROSTAT (nitroglycerin) submitted by Viatris Specialty LLC, resulting in changes associate…

• FDA approval · 2017-12-19
  FDA Approved: NIFEDIPINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for a generic nifedipine product by Zydus Lifesciences Limited. The approval covers nifedipine for the…

• FDA approval · 2017-12-13
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for diltiazem hydrochloride filed by Hospira, Inc., signaling an additional approval related to the …

• FDA approval · 2017-11-17
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

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

• FDA approval · 2017-09-19
  FDA Approved: NITROGLYCERIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original application for nitroglycerin from Glenmark Pharmaceuticals Inc., USA, granting a generic nitroglycerin product ma…

• FDA approval · 2017-08-11
  FDA Approved: TIADYLT ER — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approves TIADYLT ER (diltiazem hydrochloride extended-release) from Zydus Pharmaceuticals (USA) Inc. under an original ANDA, providing a…

• 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 · 2017-07-28
  FDA Approved: NADOLOL — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved Nadolol as a generic drug in an Original Application (ANDA) for Zydus Pharmaceuticals USA Inc.

• FDA approval · 2017-06-08
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's diltiazem hydrochloride as a generic product under an original ANDA.

• FDA approval · 2017-05-05
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Nivagen Pharmaceuticals, Inc.)

  The FDA approved the original application for verapamil hydrochloride from Nivagen Pharmaceuticals, Inc. as a generic product.

• 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 · 2017-01-11
  FDA Approved: BISOPROLOL FUMARATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' Bisoprolol Fumarate (bisoprolol fumarate) via an Original Application; indicated for hypertension and …