Hypertension

• FDA approval · 2011-01-27
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Diltiazem Hydrochloride from Teva Pharmaceuticals USA, Inc., updating the product's regulato…

• FDA approval · 2011-01-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for furosemide from Ipca Laboratories Limited under an ANDA, signaling approval of changes to the ge…

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., updating or adding to the product's labeling and…

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for furosemide, a generic diuretic, under the existing ANDA.

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide filed by Hikma Pharmaceuticals USA Inc., updating the approved generic product un…

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• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., authorizing a change to the NDA (such as lab…

• FDA approval · 2011-01-26
  FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s clonidine hydrochloride generic under ANDA200300, authorizing its marketing as a generic a…

• FDA approval · 2011-01-25
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) submitted by Waylis Therapeutics LLC.

• FDA approval · 2011-01-25
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC. The action represents a label-related c…

• FDA approval · 2011-01-20
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for diltiazem hydrochloride (Apotex Corp.), a generic calcium channel blocker. The approval covers t…

• FDA approval · 2011-01-18
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lisinopril and Hydrochlorothiazide from Aurobindo Pharma Limited. The action represents an appro…

• FDA approval · 2011-01-12
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for RAMIPRIL (ramipril) from Hikma Pharmaceuticals USA Inc., allowing a generic ramipril product to …

• FDA approval · 2011-01-06
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC.

• FDA approval · 2011-01-06
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) submitted by Waylis Therapeutics LLC.

• FDA approval · 2011-01-04
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) submitted by Novartis Pharmaceutic…

• FDA approval · 2010-12-27
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ramipril from Hikma Pharmaceuticals USA Inc., likely related to labeling or formulation changes …

• FDA approval · 2010-12-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide filed by Chartwell RX, LLC, authorizing changes under the supplemental NDA. The appro…

• FDA approval · 2010-11-30
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Enalapril Maleate and Hydrochlorothiazide from Dr. Reddy's Laboratories, approving a change to a…

• FDA approval · 2010-11-29
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for the generic drug trandolapril from Aurobindo Pharma Limited.

• FDA approval · 2010-11-23
  FDA Approved: CARDIZEM LA — Supplemental Application (Bausch Health US LLC)

  FDA's entry shows a supplemental application submission for Cardizem LA (diltiazem hydrochloride extended-release). The sponsor is Bausch He…

• FDA approval · 2010-11-22
  FDA Approved: CARDIZEM CD — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental NDA for Cardizem CD (diltiazem hydrochloride) submitted by Bausch Health US LLC.

• FDA approval · 2010-11-16
  FDA Approved: LOSARTAN POTASSIUM 25 MG — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Losartan Potassium 25 mg from Strides Pharma Science Limited, adding a new dosage strength to th…

• FDA approval · 2010-11-01
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Hydralazine Hydrochloride (generic) from Teva Pharmaceuticals USA, Inc., authorizing the generic…

• FDA approval · 2010-11-01
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA has approved a supplemental application for Hydralazine hydrochloride from Teva Pharmaceuticals USA, Inc., supporting an update to a…

• FDA approval · 2010-11-01
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydralazine hydrochloride (Teva Pharmaceuticals USA, Inc.) under ANDA 089097, updating an alread…