Hypertension

• FDA approval · 2020-10-15
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for Verapamil hydrochloride from Zydus Pharmaceuticals USA Inc., confirming the generic formulation of…

• FDA approval · 2020-10-13
  FDA Approved: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a fixed-dose combination tablet of amlodipine and benazepril hydrochloride by Rising Pharma Hold…

• FDA approval · 2020-10-02
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AZOR (amlodipine besilate and olmesartan medoxomil) submitted by Cosette Pharmaceuticals, In…

• FDA approval · 2020-10-02
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TRIBENZOR (olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide) submitted by Cosett…

• FDA approval · 2020-09-30
  FDA Approved: LABETALOL HYDROCHLORIDE — Original Application (Epic Pharma, LLC)

  FDA approved the original application for a generic labetalol hydrochloride product from Epic Pharma, LLC.

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• FDA approval · 2020-09-17
  FDA Approved: LISINOPRIL — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for lisinopril by Exelan Pharmaceuticals Inc., related to a generic lisinopril product. This ref…

• FDA approval · 2020-09-15
  FDA Approved: LISINOPRIL — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC's generic lisinopril (LISINOPRIL) under an original ANDA for the same indications as the brand. Indications i…

• FDA approval · 2020-09-08
  FDA Approved: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for amlodipine and benazepril hydrochloride, enabling marketing of the combination antihypertensive …

• FDA approval · 2020-08-20
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXFORGE HCT (amlodipine/valsartan/hydrochlorothiazide) from Novartis Pharmaceuticals Corporation…

• FDA approval · 2020-08-20
  FDA Approved: ZESTORETIC — Supplemental Application (Almatica Pharma Inc.)

  The FDA granted approval of a supplemental application for ZESTORETIC (lisinopril/hydrochlorothiazide) submitted by Almatica Pharma Inc.

• FDA approval · 2020-08-20
  FDA Approved: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for the combination drug candesartan cilexetil and hydrochlorothiazide by ANI Pharmaceuticals, u…

• FDA approval · 2020-08-20
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for the combination drug benazepril hydrochloride and hydrochlorothiazide, manufactured by Padag…

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Hydrochlorothiazide from Aurobindo Pharma Limited. The decision updates the approved generic pro…

• FDA approval · 2020-08-20
  FDA Approved: AVALIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for AVALIDE (irbesartan and hydrochlorothiazide) submitted by Sanofi-Aventis U.S. LLC. The product i…

• FDA approval · 2020-08-20
  FDA Approved: VASERETIC — Supplemental Application (Bausch Health US, LLC)

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

• FDA approval · 2020-08-20
  FDA Approved: FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (CIPLA USA INC.)

  FDA approved a supplemental application for the combination drug fosinopril sodium and hydrochlorothiazide submitted by CIPLA USA INC.

• FDA approval · 2020-08-20
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Tribenzor (olmesartan medoxomil/amlodipine besylate/hydrochlorothiazide) from Cosette Pharma…

• FDA approval · 2020-08-20
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for the fixed-dose combination spironolactone and hydrochlorothiazide.

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from Accord Healthcare Inc., approving changes under the supplemental submis…

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from ScieGen Pharmaceuticals, Inc., under an ANDA.

• FDA approval · 2020-08-20
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare LLC)

  The FDA approved a supplemental application for a generic fixed-dose combination tablet of lisinopril and hydrochlorothiazide by Solco Healt…

• FDA approval · 2020-08-20
  FDA Approved: AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for amiloride hydrochloride and hydrochlorothiazide from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for HYDROCHLOROTHIAZIDE from Oxford Pharmaceuticals, LLC, authorizing regulatory approval for th…

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Leading Pharma, LLC)

  The FDA approved a supplemental application for hydrochlorothiazide submitted by Leading Pharma, LLC.

• FDA approval · 2020-08-20
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for the fixed-dose combination bisoprolol fumarate and hydrochlorothiazide from Teva Pharmaceuticals…