Hypertension

• FDA approval · 2020-03-13
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved Jubilant Cadista Pharmaceuticals' supplemental application for Losartan Potassium and Hydrochlorothiazide, a generic combinatio…

• FDA approval · 2020-03-11
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for carvedilol (Advagen Pharma Ltd) under an ANDA, authorizing a supplemental approval for this gene…

• FDA approval · 2020-03-09
  FDA Approved: EDARBYCLOR — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  The FDA approved a supplemental application for EDARBYCLOR, a fixed-dose combination of azilsartan medoxomil and chlorthalidone, manufacture…

• FDA approval · 2020-03-06
  FDA Approved: EDARBI — Supplemental Application (Azurity Pharmaceuticals, Inc.)

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

• FDA approval · 2020-03-04
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for the fixed-dose combination of losartan potassium and hydrochlorothiazide by Teva Pharmaceuti…

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• FDA approval · 2020-03-03
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for the generic combination product Losartan Potassium and Hydrochlorothiazide, marketed by NorthSta…

• FDA approval · 2020-03-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for CAPTOPRIL by Camber Pharmaceuticals, granting approval of an additional generic captopril produc…

• FDA approval · 2020-03-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for CAPTOPRIL (captopril) from Hikma Pharmaceuticals USA Inc. under an ANDA. The action concerns…

• FDA approval · 2020-03-03
  FDA Approved: CARVEDILOL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for carvedilol from Quallent Pharmaceuticals Health LLC, approving an updated generic product.

• FDA approval · 2020-03-02
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for carvedilol from Teva Pharmaceuticals USA, resulting in updated labeling. The approval confirms c…

• FDA approval · 2020-02-24
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic fixed-dose combination of losartan potassium and hydrochlorothiazide, manufactured…

• FDA approval · 2020-02-21
  FDA Approved: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for amlodipine and benazepril hydrochloride from Heritage Pharmaceuticals (d/b/a Avet) to market…

• FDA approval · 2020-02-21
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for a generic fixed-dose combination tablet containing amlodipine besylate …

• FDA approval · 2020-02-21
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE from Unichem Pharmaceuticals (USA), Inc., maintai…

• FDA approval · 2020-02-21
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from Macleods Pharmaceuticals Limited under an AN…

• FDA approval · 2020-02-21
  FDA Approved: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a generic amlodipine and benazepril hydrochloride product from Rising Pharma Holdings, expanding…

• FDA approval · 2020-02-19
  FDA Approved: ETHACRYNIC ACID — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith's original generic application for Ethacrynic acid, a loop diuretic.

• FDA approval · 2020-02-10
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for LOTREL (amlodipine besylate and benazepril hydrochloride) by Novartis Pharmaceuticals Corporatio…

• FDA approval · 2020-01-06
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Lannett Company, Inc.)

  FDA approved the original application for propranolol hydrochloride from Lannett Company, Inc., enabling a generic version to be marketed.

• FDA approval · 2019-12-20
  FDA Approved: OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Par Health USA’s generic fixed-dose combination tablet of olmesartan medoxomil, amlodipine b…

• FDA approval · 2019-12-19
  FDA Approved: CONJUPRI — Original Application (CSPC Ouyi Pharmaceutical Co. Ltd)

  FDA approved CONJUPRI (levamlodipine) through an Original Application by CSPC Ouyi Pharmaceutical Co. Ltd for indications including hyperten…

• FDA approval · 2019-12-18
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the amlodipine besylate and atorvastatin calcium combination product, submitted by Prasco Labora…

• FDA approval · 2019-12-13
  FDA Approved: CAPTOPRIL — Original Application (Ajanta Pharma USA Inc.)

  This document reports the FDA approval of CAPTOPRIL as a generic product (Original Application) by Ajanta Pharma USA Inc.

• FDA approval · 2019-12-10
  FDA Approved: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for a fixed-dose combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide manufactur…

• FDA approval · 2019-11-29
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' generic sodium nitroprusside under an Original Application (ANDA) for sale as a vasodilator to rapidl…