Hypertension

• FDA approval · 2008-10-21
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Metoprolol Tartrate from Mylan Pharmaceuticals Inc., authorizing a generic version to be mar…

• FDA approval · 2008-10-21
  FDA Approved: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Metoprolol tartrate and hydrochlorothiazide by Mylan Pharmaceuticals Inc., updating labeling for…

• FDA approval · 2008-10-14
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amlodipine besylate filed by Zydus Pharmaceuticals USA Inc., under the ANDA process.

• FDA approval · 2008-10-08
  FDA Approved: BYSTOLIC — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for BYSTOLIC (nebivolol hydrochloride).

• FDA approval · 2008-09-30
  FDA Approved: CARVEDILOL — Supplemental Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved a supplemental application for carvedilol from Unichem Pharmaceuticals (USA), Inc., expanding labeling for this product.

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• FDA approval · 2008-09-12
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' Hydralazine Hydrochloride under an Original Application (ANDA).

• FDA approval · 2008-09-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride from Hikma Pharmaceuticals USA Inc., indicating regulatory approval of…

• FDA approval · 2008-08-29
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Atenolol from Zydus Lifesciences Limited under the ANDA.

• FDA approval · 2008-08-22
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for lisinopril from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. to market a generi…

• FDA approval · 2008-08-22
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA granted supplemental approval for a benazepril hydrochloride product (Solco Healthcare U.S., LLC), a generic ACE inhibitor used to m…

• FDA approval · 2008-08-22
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for CARVEDILOL from Dr. Reddy's Laboratories Limited, authorizing its generic carvedilol product for…

• FDA approval · 2008-08-18
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Benazepril hydrochloride from Aurobindo Pharma Limited.

• FDA approval · 2008-08-15
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Exelan Pharmaceuticals Inc.)

  The FDA approved Exelan Pharmaceuticals Inc.'s original application for hydrochlorothiazide, a generic diuretic indicated for hypertension a…

• FDA approval · 2008-08-07
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZOR (amlodipine besylate and olmesartan medoxomil) from Cosette Pharmaceuticals, Inc. AZOR is a…

• FDA approval · 2008-08-01
  FDA Approved: CLEVIPREX — Original Application (Fresenius Kabi Austria GmbH)

  FDA approved CLEVIPREX (clevidipine) from Fresenius Kabi Austria GmbH in an Original Application (NDA022156) for short-term intravenous mana…

• FDA approval · 2008-07-31
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved Baxter Healthcare's supplemental application for Cardene IV (nicardipine hydrochloride), adding an intravenous formulation …

• FDA approval · 2008-07-31
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for the lisinopril and hydrochlorothiazide combination from Actavis Pharma, Inc. The approval covers…

• FDA approval · 2008-07-24
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2008-07-23
  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 · 2008-07-17
  FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Diltiazem Hydrochloride Extended-Release from Endo USA, Inc., resulting in an approved update to…

• FDA approval · 2008-06-20
  FDA Approved: RAMIPRIL — Original Application (GSMS, Incorporated)

  FDA approved RAMIPRIL as a generic drug under an original Abbreviated New Drug Application (ANDA 079116) filed by GSMS, Incorporated.

• FDA approval · 2008-06-18
  FDA Approved: RAMIPRIL — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s original ANDA for ramipril, authorizing the marketing of a generic ramipril product.

• FDA approval · 2008-06-18
  FDA Approved: RAMIPRIL — Original Application (Chartwell RX, LLC.)

  The FDA approved Chartwell RX, LLC's original generic application for ramipril, enabling the marketing of a RAMIPRIL product.

• FDA approval · 2008-05-29
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for Benazepril hydrochloride and hydrochlorothiazide, indicating approved changes to the product's l…

• FDA approval · 2008-05-29
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a fixed-dose combination of amlodipine besylate and atorvastatin calcium (amlodipine and atorvas…