Hypertension

• FDA approval · 2023-02-06
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA approves a supplemental application for nicardipine hydrochloride (generic) submitted by Lifestar Pharma LLC.

• FDA approval · 2023-02-01
  FDA Approved: CATAPRES-TTS-1 — Supplemental Application (Technomed Inc.)

  FDA approved a supplemental application for CATAPRES-TTS-1 (clonidine transdermal system) by Technomed Inc.

• FDA approval · 2023-01-27
  FDA Approved: CAPTOPRIL — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical’s Original Application for CAPTOPRIL (captopril), a generic ACE inhibitor. The approval supports indi…

• FDA approval · 2023-01-18
  FDA Approved: OLMESARTAN MEDOXOMIL — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original application for Olmesartan Medoxomil, a generic version of the hypertension medication, manufactured by Novadoz Ph…

• FDA approval · 2022-12-30
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA approved an original application for prazosin hydrochloride as a generic drug manufactured by Lifestar Pharma LLC.

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• FDA approval · 2022-12-29
  FDA Approved: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for the generic fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide from Solc…

• FDA approval · 2022-12-19
  FDA Approved: MICARDIS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for MICARDIS (telmisartan) submitted by Boehringer Ingelheim Pharmaceuticals, expanding the labe…

• FDA approval · 2022-12-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for the combination product spironolactone and hydrochlorothiazide, manufactured by Prasco Laborator…

• FDA approval · 2022-12-19
  FDA Approved: MICARDIS HCT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2022-12-16
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's nicardipine hydrochloride generic under an original ANDA, enabling its marketing for indicated uses.

• FDA approval · 2022-12-16
  FDA Approved: FUROSEMIDE — Original Application (Lifestar Pharma LLC)

  FDA approved Lifestar Pharma LLC's original application for furosemide, authorizing the generic version of the diuretic for its labeled indi…

• FDA approval · 2022-12-02
  FDA Approved: OLMESARTAN MEDOXOMIL — Original Application (Solco Healthcare US, LLC.)

  The FDA approved the original application for olmesartan medoxomil from Solco Healthcare US, LLC., granting a generic option for treating hy…

• FDA approval · 2022-12-01
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for the combination drug Bisoprolol Fumarate and Hydrochlorothiazide by Unichem Pharmaceuticals (USA…

• FDA approval · 2022-11-18
  FDA Approved: NIFEDIPINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals Inc.'s nifedipine under an original ANDA, authorizing a generic nifedipine product.

• FDA approval · 2022-11-14
  FDA Approved: NEBIVOLOL — Original Application (Lifestar Pharma LLC)

  FDA approves Nebivolol as a generic drug under an original ANDA from Lifestar Pharma LLC.

• FDA approval · 2022-11-04
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Original Application (Viona Pharmaceuticals Inc)

  The FDA approves an original application for a generic fixed-dose combination of bisoprolol fumarate and hydrochlorothiazide for hypertensio…

• FDA approval · 2022-11-02
  FDA Approved: NEBIVOLOL — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for Nebivolol from Solco Healthcare US, LLC, enabling a generic Nebivolol product.

• FDA approval · 2022-11-01
  FDA Approved: IRBESARTAN — Supplemental Application (AvKARE)

  FDA approved AvKARE's supplemental application for IRBESARTAN (irbesartan).

• FDA approval · 2022-10-25
  FDA Approved: METOLAZONE — Original Application (Aarkish Pharmaceuticals NJ Inc.)

  FDA approved the original application for metolazone from Aarkish Pharmaceuticals NJ Inc., granting clearance to manufacture and market a ge…

• FDA approval · 2022-10-24
  FDA Approved: METOLAZONE — Original Application (Ingenus Pharmaceuticals LLC)

  FDA approves Metolazone via Original Application for a generic version by Ingenus Pharmaceuticals LLC. The approval supports its use for ede…

• FDA approval · 2022-10-21
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Original Application (Biocon Pharma Inc.)

  FDA approved the original ANDA for prazosin hydrochloride from Biocon Pharma Inc., enabling a generic version of the antihypertensive medica…

• FDA approval · 2022-10-17
  FDA Approved: FUROSEMIDE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings, Inc.'s original ANDA for furosemide, authorizing a generic version of this diuretic.

• FDA approval · 2022-10-06
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' supplemental application for a generic fixed-dose combination of amlodipine and atorvastatin (amlodi…

• FDA approval · 2022-10-06
  FDA Approved: NIFEDIPINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for nifedipine from Ascend Laboratories, LLC, updating the existing nifedipine product.

• FDA approval · 2022-10-03
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Losartan Potassium from Unichem Pharmaceuticals (USA), Inc. under ANDA 203030.