Angina Pectoris

• FDA approval · 2014-01-23
  FDA Approved: FELODIPINE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for felodipine from Endo USA, Inc. under the approved ANDA.

• FDA approval · 2013-12-31
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter Healthcare Company's supplemental NDA for Nitroglycerin in Dextrose, authorizing the nitroglycerin-in-dextrose formulati…

• FDA approval · 2013-11-19
  FDA Approved: INNOPRAN XL — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' supplemental application for INNOPRAN XL (propranolol hydrochloride). The approval confirms changes to the…

• FDA approval · 2013-11-08
  FDA Approved: FELODIPINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a generic felodipine under an Abbreviated New Drug Application by Heritage Pharmaceuticals (Avet) to treat hypertension and ang…

• FDA approval · 2013-09-20
  FDA Approved: NITROGLYCERIN LINGUAL — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Nitroglycerin Lingual as a generic product under an original ANDA from Padagis Israel Pharmaceuticals Ltd.

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• FDA approval · 2013-09-12
  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 · 2013-08-30
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approves Teva Pharmaceuticals’ supplemental application for amlodipine besylate (generic) under ANDA076846. This action represents an ap…

• FDA approval · 2013-08-30
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for amlodipine besylate from Epic Pharma, enabling the generic product to be marketed.

• FDA approval · 2013-07-29
  FDA Approved: RANOLAZINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic Ranolazine for chronic angina pectoris under the Original Application (ANDA 201046).

• FDA approval · 2013-07-25
  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.

• FDA approval · 2013-07-09
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for amlodipine besylate, confirming the approval of the ANDA supplement for t…

• FDA approval · 2013-05-28
  FDA Approved: METOPROLOL TARTRATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' metoprolol tartrate as an original generic product (ANDA 202871).

• FDA approval · 2013-05-02
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' supplemental application for amlodipine besylate under ANDA 076846.

• FDA approval · 2013-04-29
  FDA Approved: METOPROLOL — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter's generic metoprolol tartrate (METOPROLOL TARTRATE) as an Original Application. The approval supports the generic produc…

• FDA approval · 2013-04-25
  FDA Approved: NIFEDIPINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a generic nifedipine product from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. under ANDA 202644.

• FDA approval · 2013-03-18
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2013-03-14
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for Lopressor (metoprolol tartrate) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2013-02-27
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for metoprolol tartrate from Hospira, Inc., indicating an updated regulatory action on the generic p…

• FDA approval · 2013-02-01
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter's Supplemental Application for Nitroglycerin in Dextrose, adding this intravenous nitroglycerin formulation to the appro…

• FDA approval · 2013-01-10
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Nicardipine hydrochloride from Hikma Pharmaceuticals USA Inc., granting regulatory approval …

• FDA approval · 2013-01-07
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for NORVASC (amlodipine besylate) submitted by Viatris Specialty LLC. The approval is related to…

• FDA approval · 2012-12-07
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s generic diltiazem hydrochloride (ANDA 202463). The product is indicated for the management of hypertensi…

• FDA approval · 2012-11-26
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for verapamil hydrochloride from Actavis Pharma, Inc. for an already authorized product.

• FDA approval · 2012-08-24
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental abbreviated new drug application for diltiazem hydrochloride from Sun Pharmaceutical, a generic calcium channel …

• FDA approval · 2012-05-23
  FDA Approved: FELODIPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for felodipine submitted by Torrent Pharmaceuticals Limited, authorizing an update to an already app…