Hypertension

• FDA approval · 2016-02-28
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  The FDA has approved a supplemental application for RAMIPRIL, allowing Chartwell RX, LLC to market a RAMIPRIL generic product.

• FDA approval · 2016-02-25
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for enalapril maleate from Taro Pharmaceuticals U.S.A., Inc., confirming approval of a generic e…

• FDA approval · 2016-02-24
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC.

• FDA approval · 2016-02-23
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for CAPTOPRIL from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2016-02-18
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for carvedilol submitted by Teva Pharmaceuticals USA, Inc., authorizing a generic carvedilol product…

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• FDA approval · 2016-02-18
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for enalapril maleate from Northstar RxLLC. The approval confirms changes associated with this gener…

• FDA approval · 2016-02-18
  FDA Approved: QUINAPRIL — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Quinapril submitted by BluePoint Laboratories. The action updates the drug’s labeling.

• FDA approval · 2016-02-18
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Enalapril Maleate from Northstar RxLLC under an ANDA.

• FDA approval · 2016-02-16
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Ramipril (generic ACE inhibitor) under ANDA 077626, enabling a generic …

• FDA approval · 2016-02-16
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental application for CAPTOPRIL (captopril) under an existing ANDA. The action confirms continue…

• FDA approval · 2016-02-16
  FDA Approved: QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental ANDA for quinapril hydrochloride/hydrochlorothiazide from Aurobindo Pharma Limited. The product is a generic ant…

• FDA approval · 2016-02-12
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for the fixed-dose combination of benazepril hydrochloride and hydrochlorothiazide from Padagis …

• FDA approval · 2016-02-12
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approves a supplemental application for EXFORGE HCT (amlodipine, valsartan, and hydrochlorothiazide) from Novartis Pharmaceuticals C…

• FDA approval · 2016-02-11
  FDA Approved: QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a quinapril hydrochloride and hydrochlorothiazide fixed-dose combination ge…

• FDA approval · 2016-02-11
  FDA Approved: BENICAR HCT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) from Cosette Pharmaceuticals, Inc. Th…

• FDA approval · 2016-02-09
  FDA Approved: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for the fixed-dose combination candesartan cilexetil and hydrochlorothiazide manufactured by ANI Pharmaceuti…

• FDA approval · 2016-02-08
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) from Novartis Pharmaceuticals Corporat…

• FDA approval · 2016-02-08
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Solco Healthcare US, LLC)

  FDA approved an original application for a generic fixed-dose combination of valsartan and hydrochlorothiazide by Solco Healthcare US, LLC.

• FDA approval · 2016-02-05
  FDA Approved: AVALIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Avalide (irbesartan and hydrochlorothiazide) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2016-02-05
  FDA Approved: AVAPRO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for AVAPRO (irbesartan) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2016-02-05
  FDA Approved: AMLODIPINE AND VALSARTAN — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for a generic fixed-dose combination of amlodipine and valsartan by Strides Pharma Science Limited f…

• FDA approval · 2016-02-02
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC.

• FDA approval · 2016-01-28
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for amlodipine besylate from Cipla USA Inc.

• FDA approval · 2016-01-26
  FDA Approved: NIFEDIPINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for nifedipine from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. This action repres…

• FDA approval · 2016-01-26
  FDA Approved: FOSINOPRIL SODIUM — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for fosinopril sodium (fosinopril) submitted by Cipla USA Inc., enabling continued marketing of …