Hypertension

• FDA approval · 2010-01-28
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for enalapril maleate from Taro Pharmaceuticals U.S.A., Inc., authorizing the generic product under …

• FDA approval · 2010-01-25
  FDA Approved: INDAPAMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for indapamide from Rising Pharma Holdings, Inc., enabling updated labeling for the generic diur…

• FDA approval · 2010-01-19
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for metoprolol tartrate submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2010-01-19
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• FDA approval · 2010-01-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved an original application for a generic hydrochlorothiazide from Unichem Pharmaceuticals (USA), Inc. under an ANDA; the produ…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2010-01-14
  FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for doxazosin submitted by Mylan Pharmaceuticals.

• FDA approval · 2010-01-13
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Cardene IV, a new intravenous formulation of nicardipine hydrochloride by Baxter Healthcare …

• FDA approval · 2009-12-28
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for a generic fixed-dose combination of benazepril hydrochloride and hydrochlorothiazide from Sandoz…

• FDA approval · 2009-12-24
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2009-12-22
  FDA Approved: CARVEDILOL — Original Application (Advagen Pharma Limited)

  FDA approves the original application for a generic carvedilol product by Advagen Pharma Limited.

• FDA approval · 2009-12-16
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Verapamil Hydrochloride filed by Wilshire Pharmaceuticals, Inc.

• FDA approval · 2009-12-04
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approves a supplemental application for Cipla USA's amlodipine besylate, a generic product containing amlodipine besylate. The approval …

• FDA approval · 2009-12-03
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for verapamil hydrochloride by Mylan Pharmaceuticals Inc., enabling the generic version to be market…

• FDA approval · 2009-12-03
  FDA Approved: CLONIDINE — Original Application (TruPharma, LLC)

  FDA approved a clonidine product via an Original Application from TruPharma, LLC.

• FDA approval · 2009-11-18
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for lisinopril from Quallent Pharmaceuticals Health LLC, approving this generic lisinopril product.

• FDA approval · 2009-11-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Civica, Inc.)

  FDA approved Civica, Inc.'s nicardipine hydrochloride as an original generic application (ANDA 090534), making a generic version of this cal…

• FDA approval · 2009-11-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA approved the original application for nicardipine hydrochloride from Lifestar Pharma LLC, a generic version of the calcium channel block…

• FDA approval · 2009-11-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Archis Pharma LLC)

  FDA approved an original application for a generic NICARDIPINE HYDROCHLORIDE product from Archis Pharma LLC.

• FDA approval · 2009-11-13
  FDA Approved: CATAPRES-TTS-1 — Supplemental Application (Technomed Inc.)

  The FDA approved a supplemental application for CATAPRES-TTS-1, the clonidine transdermal system, from Technomed Inc., signaling regulatory …

• FDA approval · 2009-11-10
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for benazepril hydrochloride and hydrochlorothiazide, expanding the labeling for this fixed-dose com…

• FDA approval · 2009-11-10
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application to allow Prasco Laboratories to market aliskiren hemifumarate.

• FDA approval · 2009-11-06
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for a generic fixed-dose combination of bisoprolol fumarate and hydrochlorothiazide, expanding avail…

• FDA approval · 2009-10-30
  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. to update t…

• FDA approval · 2009-10-29
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA granted supplemental approval for Lupin Pharmaceuticals’ ramipril generic under the ANDA, authorizing continued marketing of the product…

• FDA approval · 2009-10-22
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for RAMIPRIL submitted by Chartwell RX, LLC., indicating approval of a supplemental filing related t…