Myocardial Infarction

• FDA approval · 2011-09-13
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approves a supplemental application for Atenolol by Zydus Lifesciences Limited under an ANDA, authorizing an approved supplemental actio…

• FDA approval · 2011-08-17
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for Tenormin (atenolol) from Almatica Pharma LLC.

• FDA approval · 2011-07-22
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for CAPTOPRIL from Hikma Pharmaceuticals USA Inc., indicating additional approval for this generic A…

• FDA approval · 2011-07-20
  FDA Approved: BRILINTA — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved Brilinta (ticagrelor) through an original application for use in patients with acute coronary syndrome to reduce the risk of ca…

• FDA approval · 2011-07-06
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC, resulting in labeling updates for the d…

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• FDA approval · 2011-07-06
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) submitted by Waylis Therapeutics LLC. The action finalizes the r…

• FDA approval · 2011-06-08
  FDA Approved: RAMIPRIL — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings' original application for ramipril (generic ramipril), enabling the company to market a ramipril pro…

• FDA approval · 2011-04-01
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for carvedilol from Teva Pharmaceuticals USA, Inc., authorizing the marketing of the generic car…

• 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 · 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 · 2010-12-06
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' supplemental application for EFFIENT (prasugrel hydrochloride).

• FDA approval · 2010-10-25
  FDA Approved: METOPROLOL — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original ANDA for metoprolol tartrate by Fresenius Kabi USA, LLC, a generic beta-blocker. It is indicated for hypertension,…

• FDA approval · 2010-07-23
  FDA Approved: ENOXAPARIN SODIUM — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's Original Application for Enoxaparin Sodium, a generic injectable anticoagulant. The approval authorizes marketing …

• FDA approval · 2010-07-06
  FDA Approved: ATENOLOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for atenolol submitted by Rising Pharma Holdings, Inc.

• FDA approval · 2010-05-18
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's supplemental application for clopidogrel bisulfate, a generic version of clopidogrel. The ap…

• FDA approval · 2010-05-07
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' lisinopril supplemental application (ANDA 075903), making a generic lisinopril tablet available with ap…

• FDA approval · 2010-03-12
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited.

• FDA approval · 2010-03-10
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for metoprolol tartrate.

• FDA approval · 2010-01-28
  FDA Approved: QUINAPRIL — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Quinapril submitted by Cipla USA Inc. The approval confirms continued availability of Quinapril …

• 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 · 2010-01-19
  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 · 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 · 2009-10-29
  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…

• FDA approval · 2009-10-22
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for ramipril submitted by Hikma Pharmaceuticals USA Inc. The action confirms continued approval …