Angina Pectoris

• FDA approval · 2011-06-03
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Torrent Pharmaceuticals Limited)

  The FDA approved a generic isosorbide mononitrate product from Torrent Pharmaceuticals Limited via an original application.

• FDA approval · 2011-06-03
  FDA Approved: ISOSORBIDE MONONITRATE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited’s Original Application for Isosorbide Mononitrate, a generic nitrate used to prevent angina pec…

• FDA approval · 2011-04-29
  FDA Approved: ISOSORBIDE MONONITRATE — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  The FDA approved a supplemental application for Isosorbide Mononitrate submitted by Edenbridge Pharmaceuticals LLC.

• FDA approval · 2011-03-22
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (PD-Rx Pharmaceuticals, Inc.)

  FDA approved a supplemental application for amlodipine besylate (PD-Rx Pharmaceuticals, Inc.) under an ANDA. This action updates the approve…

• FDA approval · 2011-03-17
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Inderal LA (propranolol hydrochloride) filed by ANI Pharmaceuticals, Inc.

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• FDA approval · 2011-02-11
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for amlodipine besylate from Cipla USA Inc., representing a supplemental approval for a generic prod…

• FDA approval · 2011-02-07
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for CARDENE IV (nicardipine hydrochloride) from Baxter Healthcare Corporation, related to the IV for…

• FDA approval · 2011-01-27
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Diltiazem Hydrochloride from Teva Pharmaceuticals USA, Inc., updating the product's regulato…

• FDA approval · 2011-01-20
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for diltiazem hydrochloride (Apotex Corp.), a generic calcium channel blocker. The approval covers t…

• FDA approval · 2010-11-23
  FDA Approved: CARDIZEM LA — Supplemental Application (Bausch Health US LLC)

  FDA's entry shows a supplemental application submission for Cardizem LA (diltiazem hydrochloride extended-release). The sponsor is Bausch He…

• FDA approval · 2010-11-22
  FDA Approved: CARDIZEM CD — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental NDA for Cardizem CD (diltiazem hydrochloride) submitted by Bausch Health US LLC.

• FDA approval · 2010-10-25
  FDA Approved: METOPROLOL — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original ANDA for metoprolol tartrate by Fresenius Kabi USA, LLC, a generic beta-blocker. It is indicated for hypertension,…

• FDA approval · 2010-10-22
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for amlodipine besylate.

• FDA approval · 2010-10-04
  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, indicating changes under …

• FDA approval · 2010-08-12
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for verapamil hydrochloride from Mylan Pharmaceuticals Inc., granting/confirming approval for a …

• FDA approval · 2010-07-12
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Nitrostat (nitroglycerin) submitted by Viatris Specialty LLC, resulting in an updated labeli…

• FDA approval · 2010-07-06
  FDA Approved: ATENOLOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for atenolol submitted by Rising Pharma Holdings, Inc.

• FDA approval · 2010-06-30
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for amlodipine besylate by Aurobindo Pharma Limited as a generic product.

• FDA approval · 2010-05-11
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amlodipine besylate from Zydus Pharmaceuticals USA Inc., granting approval for the generic produ…

• FDA approval · 2010-04-30
  FDA Approved: AMLODIPINE BESYLATE 2.5 MG — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application to allow amlodipine besylate 2.5 mg as an additional dosage strength for Oxford Pharmaceuticals' pro…

• FDA approval · 2010-04-07
  FDA Approved: AMLODIPINE BESYLATE 2.5 MG — Original Application (Oxford Pharmaceuticals, LLC)

  FDA approved the Original Application for amlodipine besylate 2.5 mg by Oxford Pharmaceuticals, LLC.

• FDA approval · 2010-03-15
  FDA Approved: MATZIM LA — Original Application (Actavis Pharma, Inc.)

  FDA approved MATZIM LA, a diltiazem hydrochloride extended-release tablet, under Actavis Pharma's original ANDA.

• FDA approval · 2010-03-12
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2010-03-10
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for metoprolol tartrate.

• FDA approval · 2010-02-17
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for NORVASC (amlodipine besylate) submitted by Viatris Specialty LLC.