Heart Failure

• FDA approval · 2007-08-09
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide submitted by Solco Healthcare LLC.

• FDA approval · 2007-08-06
  FDA Approved: DIURIL — Supplemental Application (Salix Pharmaceuticals, Inc)

  The FDA approved a supplemental application for Salix's Diuril (chlorothiazide), approving changes to its labeling as part of the supplement…

• FDA approval · 2007-08-03
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved Waylis Therapeutics LLC's supplemental application for COREG CR, the extended-release formulation of carvedilol phosphate.

• FDA approval · 2007-07-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for HYDROCHLOROTHIAZIDE from Aurobindo Pharma Limited, approving a generic hydrochlorothiazide product…

• FDA approval · 2007-07-16
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

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

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2007-06-29
  FDA Approved: FUROSEMIDE — Supplemental Application (Leading Pharma, LLC)

  FDA approves a supplemental application for furosemide submitted by Leading Pharma, LLC.

• FDA approval · 2007-06-14
  FDA Approved: DIGOXIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Digoxin from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2007-03-28
  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 ANDA.

• FDA approval · 2007-03-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide by Hikma Pharmaceuticals USA Inc., approving regulatory action on an existing generic…

• FDA approval · 2007-03-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., resulting in changes to the product labeling…

• FDA approval · 2007-02-27
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved a generic hydrochlorothiazide under an original ANDA from Actavis Pharma, Inc.

• FDA approval · 2007-02-13
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA supplemental approval for Camber Pharmaceuticals' lisinopril generic under ANDA075903. Lisinopril is used to treat hypertension, heart f…

• FDA approval · 2007-02-08
  FDA Approved: MILRINONE LACTATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for milrinone lactate (Fresenius Kabi USA, LLC), indicating FDA approval of the supplemental submiss…

• FDA approval · 2007-02-06
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for lisinopril from Aurobindo Pharma Limited, authorizing a generic lisinopril product under an ANDA…

• FDA approval · 2007-01-30
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for lisinopril filed by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2007-01-19
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Digoxin (DIGOXIN) from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2007-01-10
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

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

• FDA approval · 2006-10-20
  FDA Approved: COREG CR — Original Application (Waylis Therapeutics LLC)

  FDA approved COREG CR, an extended-release formulation of carvedilol phosphate, under an original NDA from Waylis Therapeutics LLC.

• FDA approval · 2006-09-18
  FDA Approved: FUROSEMIDE — Original Application (Ipca Laboratories Limited)

  FDA approved the Original Application for furosemide from Ipca Laboratories Limited, enabling a generic version of the diuretic to be market…

• FDA approval · 2006-08-28
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2006-08-17
  FDA Approved: ATACAND — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ATACAND (candesartan cilexetil) submitted by ANI Pharmaceuticals, Inc., to modify or expand the …

• FDA approval · 2006-08-08
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for lisinopril from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2006-07-27
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for TOPROL XL (metoprolol succinate) from Melinta Therapeutics, LLC. The approval updates the pr…

• FDA approval · 2006-07-03
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for lisinopril, authorizing the continued marketing of its lisinopril gene…

• FDA approval · 2006-06-20
  FDA Approved: QUINAPRIL — Original Application (BluePoint Laboratories)

  FDA approved the original ANDA for Quinapril from BluePoint Laboratories, establishing a generic version of the ACE inhibitor used to treat …