Hypertension

• FDA approval · 2011-05-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the Spironolactone and Hydrochlorothiazide combination submitted by Prasco Laboratories.

• FDA approval · 2011-05-12
  FDA Approved: MICARDIS HCT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for MICARDIS HCT (telmisartan/hydrochlorothiazide) from Boehringer Ingelheim Pharmaceuticals, In…

• FDA approval · 2011-05-03
  FDA Approved: BENICAR HCT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for BENICAR HCT (olmesartan medoxomil-hydrochlorothiazide) by Cosette Pharmaceuticals, Inc.

• FDA approval · 2011-05-03
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for the fixed-dose combination of bisoprolol fumarate and hydrochlorothiazide. This action updates t…

• FDA approval · 2011-04-21
  FDA Approved: MATZIM LA — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for MATZIM LA (diltiazem hydrochloride) by Actavis Pharma, Inc.

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• FDA approval · 2011-04-20
  FDA Approved: QUINAPRIL AND HYDROCHLOROTHIAZIDE 10/12.5 — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s quinapril and hydrochlorothiazide 10/12.5 as an original ANDA (with similar products 20/12.5 and 20/25) for th…

• FDA approval · 2011-04-12
  FDA Approved: EDARBI — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EDARBI (azilsartan medoxomil) submitted by Azurity Pharmaceuticals, Inc.

• FDA approval · 2011-04-01
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for carvedilol from Teva Pharmaceuticals USA, Inc., authorizing the marketing of the generic car…

• FDA approval · 2011-03-31
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for prazosin hydrochloride (generic) under Mylan Pharmaceuticals Inc., expanding access to the gener…

• FDA approval · 2011-03-30
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Losartan Potassium from Alembic Pharmaceuticals Limited, confirming approval of a generic produc…

• FDA approval · 2011-03-30
  FDA Approved: FOSINOPRIL SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for fosinopril sodium from Aurobindo Pharma Limited, making it a generic product.

• FDA approval · 2011-03-25
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA notice related to a supplemental application for Tribenzor (olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide) by Cosette…

• FDA approval · 2011-03-22
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Losartan Potassium submitted by Quallent Pharmaceuticals Health 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.

• FDA approval · 2011-03-11
  FDA Approved: ZESTORETIC — Supplemental Application (Almatica Pharma Inc.)

  FDA approved a supplemental application for ZESTORETIC (lisinopril and hydrochlorothiazide) from Almatica Pharma Inc.

• FDA approval · 2011-03-11
  FDA Approved: VASERETIC — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for VASERETIC (enalapril maleate and hydrochlorothiazide) from Bausch Health US, LLC.

• FDA approval · 2011-03-10
  FDA Approved: METOLAZONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for metolazone by Sandoz Inc. It is a diuretic used to treat edema and hypertension.

• FDA approval · 2011-02-25
  FDA Approved: EDARBI — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approved EDARBI (azilsartan medoxomil) under the original NDA from Azurity Pharmaceuticals, Inc.

• FDA approval · 2011-02-14
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for amlodipine besylate and benazepril hydrochloride (Dr. Reddy's) as a fixed-dose generic combi…

• 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 · 2011-02-03
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from Lupin Pharmaceuticals, signaling an updated labe…

• FDA approval · 2011-02-03
  FDA Approved: LABETALOL HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for labetalol hydrochloride submitted by NorthStar Rx LLC under an ANDA. The approval confirms the r…

• FDA approval · 2011-01-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide from Solco Healthcare LLC under an ANDA, authorizing a manufacturing or labeling chan…