Hypertension

• FDA approval · 2019-07-18
  FDA Approved: OLMESARTAN MEDOXOMIL — Original Application (Lifestar Pharma LLC)

  FDA approved an original-application (ANDA) for olmesartan medoxomil from Lifestar Pharma LLC, expanding generic availability for hypertensi…

• FDA approval · 2019-07-12
  FDA Approved: ETHACRYNIC ACID — Original Application (TRUPHARMA LLC)

  FDA approves the original ANDA for Ethacrynic acid by Trupharma LLC, enabling its generic distribution as a loop diuretic. The approval cove…

• FDA approval · 2019-07-09
  FDA Approved: TELMISARTAN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approves a supplemental application for telmisartan from Ascend Laboratories, LLC, authorizing continued marketing of the generic ARB.

• FDA approval · 2019-07-08
  FDA Approved: KATERZIA — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approves KATERZIA (amlodipine) through an Original Application by Azurity Pharmaceuticals, introducing an amlodipine oral suspension. Th…

• FDA approval · 2019-07-05
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals' supplemental application for Losartan Potassium and Hydrochlorothiazide, a generic fixed-dose combinat…

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• FDA approval · 2019-07-05
  FDA Approved: LOSARTAN POTASSIUM TABLETS, 25 MG — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved Jubilant Cadista Pharmaceuticals' supplemental application for Losartan Potassium Tablets, 25 mg, under ANDA201170.

• FDA approval · 2019-07-01
  FDA Approved: CHLORTHALIDONE — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's original application for chlorthalidone, a thiazide-like diuretic used to treat hypertension a…

• FDA approval · 2019-06-24
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from Unichem Pharmaceuticals (USA), Inc., updating th…

• FDA approval · 2019-06-24
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic Losartan Potassium and Hydrochlorothiazide product from Macleods Pharmaceuticals L…

• FDA approval · 2019-06-24
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for NorthStar Rx LLC to market losartan potassium and hydrochlorothiazide, a fixed-dose combination …

• FDA approval · 2019-06-14
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved Ingenus Pharmaceuticals' generic diltiazem hydrochloride via an original ANDA submission.

• FDA approval · 2019-06-12
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Diovan HCT (valsartan/hydrochlorothiazide) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2019-06-12
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXFORGE HCT (amlodipine, valsartan, and hydrochlorothiazide) from Novartis Pharmaceuticals Corpo…

• FDA approval · 2019-06-12
  FDA Approved: DIOVAN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for DIOVAN (valsartan) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2019-06-12
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXFORGE (amlodipine besylate and valsartan) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2019-05-19
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for benazepril hydrochloride submitted by Amneal Pharmaceuticals of New York LLC, indicating an …

• FDA approval · 2019-05-17
  FDA Approved: TELMISARTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for telmisartan filed by Mylan Pharmaceuticals Inc., granting approval for the generic telmisart…

• FDA approval · 2019-05-13
  FDA Approved: LABETALOL HYDROCHLORIDE — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved labetalol hydrochloride as a generic drug under an original application from Cadila Pharmaceuticals Limited.

• FDA approval · 2019-05-10
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the generic amlodipine besylate and atorvastatin calcium combination (amlodipine and atorvastati…

• FDA approval · 2019-05-10
  FDA Approved: CHLORTHALIDONE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for chlorthalidone from Zydus Lifesciences Limited, granting generic approval under ANDA207813.

• FDA approval · 2019-05-07
  FDA Approved: TELMISARTAN AND AMLODIPINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA-approved Lupin Pharmaceuticals' supplemental application for a Telmisartan and Amlodipine fixed-dose combination, enabling the generic p…

• FDA approval · 2019-05-07
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Telmisartan and Hydrochlorothiazide, a generic combination used to treat hy…

• FDA approval · 2019-05-07
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Losartan Potassium from Unichem Pharmaceuticals (USA), Inc., authorizing the marketing of a gene…

• FDA approval · 2019-05-07
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Micro Labs Limited)

  Supplemental application for Losartan Potassium from Micro Labs Limited has been approved by the FDA.

• FDA approval · 2019-05-03
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (TRUPHARMA LLC)

  FDA approved a supplemental application for metoprolol tartrate submitted by TRUPHARMA LLC.