Hypertension

• FDA approval · 2014-09-21
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Losartan Potassium from Quallent Pharmaceuticals Health LLC to update the approved generic p…

• FDA approval · 2014-09-21
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Losartan Potassium submitted by Aurobindo Pharma Limited.

• FDA approval · 2014-09-21
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for carvedilol from Aurobindo Pharma Limited, confirming a generic version under ANDA078332.

• FDA approval · 2014-09-19
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for Losartan Potassium (generic), granting a supplemental approval for the prod…

• FDA approval · 2014-09-18
  FDA Approved: HYDRALAZINE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved the original generic application for hydralazine hydrochloride tablets from Nivagen Pharmaceuticals, Inc., for the treatment of…

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• FDA approval · 2014-09-17
  FDA Approved: CARVEDILOL — Supplemental Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  The FDA approved a supplemental application for carvedilol, submitted by Unichem Pharmaceuticals (USA), Inc. Carvedilol is a beta-blocker us…

• FDA approval · 2014-09-15
  FDA Approved: IRBESARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the supplemental application for IRBESARTAN submitted by Aurobindo Pharma Limited.

• FDA approval · 2014-09-11
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for Hydralazine hydrochloride (generic) from Teva Pharmaceuticals USA, Inc. Hydralazine is used to t…

• FDA approval · 2014-09-11
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydralazine hydrochloride from Teva Pharmaceuticals USA, Inc., authorizing a change under an AND…

• FDA approval · 2014-09-11
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Hydralazine Hydrochloride (generic) from Teva Pharmaceuticals USA, Inc. under ANDA089097, confir…

• FDA approval · 2014-09-04
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for Trandolapril tablets from Epic Pharma, LLC.

• FDA approval · 2014-08-27
  FDA Approved: METOPROLOL TARTRATE — Original Application (Almaject, Inc.)

  FDA approved Almaject, Inc.'s metoprolol tartrate as an original Abbreviated New Drug Application (ANDA), establishing a generic version of …

• FDA approval · 2014-08-26
  FDA Approved: TELMISARTAN AND AMLODIPINE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved an Original Application for a fixed-dose combination tablet of telmisartan and amlodipine by Mylan Pharmaceuticals Inc. for…

• FDA approval · 2014-08-26
  FDA Approved: TELMISARTAN — Original Application (Zydus Lifesciences Limited)

  FDA approved the original ANDA for telmisartan from Zydus Lifesciences Limited, granting marketing authorization for a generic telmisartan p…

• FDA approval · 2014-08-26
  FDA Approved: FUROSEMIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved Heritage Pharmaceuticals' generic furosemide (ANDA 203428) for edema-related indications and hypertension, enabling a generic v…

• FDA approval · 2014-08-07
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic combination tablet of telmisartan and hydrochlorothiazide (telmisartan/hydrochlorothiazide) unde…

• FDA approval · 2014-07-28
  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 · 2014-07-28
  FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for doxazosin from Mylan Pharmaceuticals Inc., signaling a regulatory action that likely updates lab…

• FDA approval · 2014-07-28
  FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Cardura XL (doxazosin mesylate) submitted by Viatris Specialty LLC.

• FDA approval · 2014-07-28
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for the fixed-dose combination of amlodipine and atorvastatin (amlodipi…

• FDA approval · 2014-07-23
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Cardene IV, authorizing an intravenous formulation of nicardipine hydrochloride for use in hospi…

• FDA approval · 2014-07-23
  FDA Approved: EDARBYCLOR — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approves a supplemental application for EDARBYCLOR, a fixed-dose combination of azilsartan medoxomil and chlorthalidone, submitted by Az…

• FDA approval · 2014-07-23
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original application for Hydrochlorothiazide (ScieGen Pharmaceuticals, Inc.), a generic diuretic. It is indicated for hyper…

• FDA approval · 2014-07-19
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2014-07-07
  FDA Approved: TELMISARTAN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's original submission for Telmisartan, a generic angiotensin II receptor blocker indicated for hypertension.