Hypertension

• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental ANDA for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC, authorizing a new generic propranolol hydro…

• FDA approval · 2014-12-05
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for captopril from Hikma Pharmaceuticals USA, documenting changes to the marketed captopril product …

• FDA approval · 2014-12-02
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application to add Cardene IV, an intravenous form of nicardipine hydrochloride by Baxter, for use in hospitaliz…

• FDA approval · 2014-11-26
  FDA Approved: QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic Quinapril hydrochloride/hydrochlorothiazide combination from Aurobindo Pharma Limi…

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• FDA approval · 2014-11-26
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for carvedilol, enabling a generic carvedilol product to be marketed.

• FDA approval · 2014-11-25
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's Losartan Potassium and Hydrochlorothiazide, updating labeling for this fixed-dose combina…

• FDA approval · 2014-11-21
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for AMLODIPINE BESYLATE submitted by Zydus Pharmaceuticals USA Inc. under ANDA 078226.

• FDA approval · 2014-11-14
  FDA Approved: AMLODIPINE AND VALSARTAN — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for a Strides Pharma amlodipine/valsartan combination product, authorizing its use for the treat…

• FDA approval · 2014-11-10
  FDA Approved: GUANFACINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma, Inc.'s supplemental application for guanfacine, enabling the generic product to enter the market.

• FDA approval · 2014-11-07
  FDA Approved: ATENOLOL — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for Atenolol from Ipca Laboratories Limited under an ANDA.

• FDA approval · 2014-11-05
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for a fixed-dose combination of amlodipine besylate and benazepril hydrochl…

• FDA approval · 2014-11-05
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Micro Labs Limited)

  FDA approves a supplemental application for losartan potassium from Micro Labs Limited.

• FDA approval · 2014-11-04
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA has granted supplemental approval for Losartan Potassium from Macleods Pharmaceuticals Limited. This action approves the supplementa…

• FDA approval · 2014-11-04
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from Macleods Pharmaceuticals Limited. The product is…

• FDA approval · 2014-11-04
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE from Taro Pharmaceuticals U.S.A., Inc., adding a g…

• FDA approval · 2014-11-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA's supplemental application for captopril (CAPTOPRIL), enabling the generic captopril product under th…

• FDA approval · 2014-10-31
  FDA Approved: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for amlodipine and benazepril hydrochloride (Rising Pharma Holdings, Inc.), granting a supplemen…

• FDA approval · 2014-10-31
  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 · 2014-10-30
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lopressor (metoprolol tartrate) from Validus Pharmaceuticals LLC.

• FDA approval · 2014-10-28
  FDA Approved: METOPROLOL TARTRATE — Original Application (TRUPHARMA LLC)

  FDA approved TRUPHARMA LLC's original ANDA for metoprolol tartrate, enabling a generic version of this beta-blocker. The approval makes meto…

• FDA approval · 2014-10-26
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for amlodipine besylate and benazepril hydrochloride from Dr. Reddy's Laboratories Limited (a generi…

• FDA approval · 2014-10-26
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Dr. Reddy's Laboratories Limited for amlodipine besylate and benazepril hydrochloride, a generic…

• FDA approval · 2014-10-22
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a generic spironolactone and hydrochlorothiazide combination product from Prasco Laboratories.

• FDA approval · 2014-10-07
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for Benicar (olmesartan medoxomil) submitted by Cosette Pharmaceuticals, Inc.