Hypertension

• FDA approval · 2022-03-15
  FDA Approved: DOXAZOSIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for doxazosin (generic) by Rising Pharma Holdings, Inc., expanding access to this alpha-1 blocker for …

• FDA approval · 2022-03-14
  FDA Approved: AMLODIPINE AND VALSARTAN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic amlodipine/valsartan combination from Aurobindo Pharma Limited, expanding the avai…

• FDA approval · 2022-03-11
  FDA Approved: AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application to authorize Aurobindo Pharma Limited's generic fixed-dose combination tablet containing amlodipine,…

• FDA approval · 2022-02-25
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for the generic combination Triamterene and Hydrochlorothiazide from BluePoint Laboratories. The…

• FDA approval · 2022-02-25
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from BluePoint Laboratories, enabling the marketing of t…

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• FDA approval · 2022-02-24
  FDA Approved: NORLIQVA — Original Application (CMP Pharma, Inc.)

  FDA approved NORLIQVA (amlodipine) from CMP Pharma as an original application. The product is indicated for the treatment of hypertension an…

• FDA approval · 2022-02-24
  FDA Approved: ENALAPRIL MALEATE ORAL SOLUTION — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's enalapril maleate oral solution as an original ANDA, enabling a generic version of enalapril maleate.

• FDA approval · 2022-02-24
  FDA Approved: CHLORTHALIDONE — Original Application (TAGI Pharma, Inc.)

  FDA approved the original generic application for chlorthalidone by TAGI Pharma, Inc., allowing market authorization for this thiazide-like …

• FDA approval · 2022-02-24
  FDA Approved: CHLORTHALIDONE — Original Application (TAGI Pharma, Inc.)

  FDA approved the original application for chlorthalidone from TAGI Pharma, confirming marketing authorization for this generic diuretic.

• FDA approval · 2022-02-23
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Original Application (Advagen Pharma Ltd)

  Original approval of Triamterene and Hydrochlorothiazide (Advagen Pharma Ltd) under an ANDA.

• FDA approval · 2022-02-14
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA granted supplemental approval for the combination drug valsartan and hydrochlorothiazide from Macleods Pharmaceuticals Limited.

• FDA approval · 2022-02-09
  FDA Approved: CHLORTHALIDONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the generic chlorthalidone under an original ANDA from Rising Pharma Holdings, Inc.

• FDA approval · 2022-02-07
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental ANDA for a generic fixed-dose combination of bisoprolol fumarate and hydrochlorothiazide manufactured by Mylan P…

• FDA approval · 2022-01-31
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's IRBESARTAN AND HYDROCHLOROTHIAZIDE, establishing approval of the generic combination prod…

• FDA approval · 2022-01-27
  FDA Approved: NEBIVOLOL — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Nebivolol filed by ANI Pharmaceuticals, Inc. for Nebivolol product.

• FDA approval · 2022-01-27
  FDA Approved: FUROSEMIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved an original generic application for furosemide from Meitheal Pharmaceuticals Inc.

• FDA approval · 2022-01-26
  FDA Approved: NEBIVOLOL — Supplemental Application (AvKARE)

  FDA approved a supplemental application for Nebivolol Hydrochloride by AvKARE, indicating an additional approval related to the generic prod…

• FDA approval · 2022-01-26
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approved an original application for a generic fixed-dose combination drug of bisoprolol fumarate and hydrochlorothiazide for hypertensi…

• FDA approval · 2022-01-24
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (AvKARE)

  FDA approved a supplemental application for a generic combination tablet of telmisartan and hydrochlorothiazide manufactured by AvKARE.

• FDA approval · 2022-01-14
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for losartan potassium and hydrochlorothiazide from Alembic Pharmaceuticals Limited, signifying an a…

• FDA approval · 2022-01-14
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic Telmisartan and Hydrochlorothiazide combination from Alembic Pharmaceuticals Limit…

• FDA approval · 2021-12-23
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for lisinopril submitted by Camber Pharmaceuticals, Inc., approving changes to the lisinopril pr…

• FDA approval · 2021-12-23
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Original Application (Exelan Pharmaceuticals)

  FDA approved the original ANDA for prazosin hydrochloride (generic) manufactured by Exelan Pharmaceuticals.

• FDA approval · 2021-12-20
  FDA Approved: IRBESARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for Irbesartan from Aurobindo Pharma Limited.

• FDA approval · 2021-12-20
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  The FDA approved a supplemental application for Hospira's verapamil hydrochloride under an existing approved product, marking an update to t…