Essential Hypertension

• FDA approval · 2026-08-20
  FDA Approved: LISINOPRIL — Original Application (ANNORA PHARMA)

  FDA approval overview for lisinopril original application by Annora Pharma.

• EMA approval · 2026-07-14
  EMA Authorised: Qaialdo (spironolactone) — Lipomed GmbH

  EMA has authorized Qaialdo, a spironolactone product by Lipomed GmbH, for several conditions including edema, heart failure, liver cirrhosis…

• EMA approval · 2026-03-24
  EMA Authorised: Qaialdo (spironolactone) — Lipomed GmbH

  Qaialdo is a spironolactone product by Lipomed GmbH that has been authorized in the EU. Indications include edema, heart failure, liver cirr…

• FDA approval · 2025-10-06
  FDA Approved: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic triple-combination tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide for esse…

• EMA approval · 2025-05-13
  EMA Authorised: Actelsar HCT (telmisartan;hydrochlorothiazide) — Actavis Group PTC ehf

  The European Medicines Agency has authorised Actelsar HCT, a fixed-dose combination of telmisartan and hydrochlorothiazide, for essential hy…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-10-23
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for hydrochlorothiazide from Oxford Pharmaceuticals, LLC. This action pertains to regulatory approva…

• FDA approval · 2023-09-14
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for the irbesartan and hydrochlorothiazide combination from Aurobindo Pharma Limited.

• FDA approval · 2023-08-25
  FDA Approved: NEBIVOLOL HYDROCHLORIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Nebivolol hydrochloride (Unichem Pharmaceuticals USA) for a generic product. Nebivolol hydrochlo…

• FDA approval · 2023-06-28
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Spironolactone from Amneal Pharmaceuticals LLC.

• FDA approval · 2016-05-05
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for benazepril hydrochloride and hydrochlorothiazide (an antihypertensive combination) submitted…

• FDA approval · 2015-04-28
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a supplemental application for Jubilant Cadista's generic losartan potassium and hydrochlorothiazide tablet, a combination anti…

• FDA approval · 2014-10-30
  FDA Approved: BYSTOLIC — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for BYSTOLIC (nebivolol hydrochloride).

• FDA approval · 2012-12-11
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2012-10-15
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for the generic fixed-dose combination of irbesartan and hydrochlorothiazide from Alembic Pharmaceutic…

• FDA approval · 2011-06-21
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2008-10-29
  FDA Approved: TENORETIC — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for TENORETIC (atenolol and chlorthalidone) from Upsher-Smith Laboratories, LLC.

• FDA approval · 2008-05-19
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for aliskiren hemifumarate by Prasco Laboratories to market the generic product.

• FDA approval · 2007-08-07
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for aliskiren hemifumarate filed by Prasco Laboratories, supporting the continued/expanded availabil…