Angina Pectoris

• FDA approval · 2010-01-19
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for metoprolol tartrate submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2010-01-19
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• FDA approval · 2010-01-13
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Cardene IV, a new intravenous formulation of nicardipine hydrochloride by Baxter Healthcare …

• FDA approval · 2009-12-16
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Verapamil Hydrochloride filed by Wilshire Pharmaceuticals, Inc.

• FDA approval · 2009-12-04
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approves a supplemental application for Cipla USA's amlodipine besylate, a generic product containing amlodipine besylate. The approval …

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• FDA approval · 2009-12-03
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for verapamil hydrochloride by Mylan Pharmaceuticals Inc., enabling the generic version to be market…

• FDA approval · 2009-11-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Civica, Inc.)

  FDA approved Civica, Inc.'s nicardipine hydrochloride as an original generic application (ANDA 090534), making a generic version of this cal…

• FDA approval · 2009-11-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA approved the original application for nicardipine hydrochloride from Lifestar Pharma LLC, a generic version of the calcium channel block…

• FDA approval · 2009-11-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Archis Pharma LLC)

  FDA approved an original application for a generic NICARDIPINE HYDROCHLORIDE product from Archis Pharma LLC.

• FDA approval · 2009-09-17
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's verapamil hydrochloride as an original generic application, adding a new generic calcium channel blocker to the mark…

• FDA approval · 2009-09-02
  FDA Approved: ATENOLOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Atenolol from Aurobindo Pharma Limited, confirming approval of a generic Atenolol product under …

• FDA approval · 2009-08-18
  FDA Approved: BISOPROLOL FUMARATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a generic version of bisoprolol fumarate from Unichem Pharmaceuticals (USA), Inc. under an Original Application. It is indicate…

• FDA approval · 2009-04-29
  FDA Approved: TECHNETIUM TC 99M SESTAMIBI — Original Application (Jubilant Draximage (USA) Inc.)

  FDA approved Jubilant Draximage (USA) Inc.'s original ANDA for Technetium Tc-99m Sestamibi, a radiopharmaceutical used in myocardial perfusi…

• FDA approval · 2009-04-08
  FDA Approved: AMLODIPINE BESYLATE — Original Application (Epic Pharma, LLC)

  The FDA approved the original application for amlodipine besylate from Epic Pharma, LLC, enabling its generic version of the calcium channel…

• FDA approval · 2009-03-12
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Teva Pharmaceuticals' amlodipine besylate (generic) product, signaling regulatory approval for t…

• FDA approval · 2009-02-26
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited, confirming regulatory clearance for the gener…

• FDA approval · 2009-02-19
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Atenolol filed by Zydus Lifesciences Limited, resulting in approval of a generic Atenolol produc…

• FDA approval · 2009-01-14
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approves a supplemental application for Atenolol by Zydus Lifesciences Limited under an ANDA; this action updates the approved Atenolol …

• FDA approval · 2008-12-17
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s original application for diltiazem hydrochloride (generic). This approval makes a generic vers…

• FDA approval · 2008-11-04
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for metoprolol tartrate by Hospira, Inc., indicating regulatory action on this generic product. The …

• FDA approval · 2008-10-21
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for amlodipine besylate from Aurobindo Pharma Limited (ANDA 078021). This action approves change…

• FDA approval · 2008-10-21
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Metoprolol Tartrate from Mylan Pharmaceuticals Inc., authorizing a generic version to be mar…

• FDA approval · 2008-10-14
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amlodipine besylate filed by Zydus Pharmaceuticals USA Inc., under the ANDA process.

• FDA approval · 2008-10-01
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for nitroglycerin by Prasco Laboratories, updating the NDA with additional labeling/indication.

• FDA approval · 2008-09-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride from Hikma Pharmaceuticals USA Inc., indicating regulatory approval of…