Myocardial Infarction

• FDA approval · 2013-04-29
  FDA Approved: METOPROLOL — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter's generic metoprolol tartrate (METOPROLOL TARTRATE) as an Original Application. The approval supports the generic produc…

• FDA approval · 2013-04-29
  FDA Approved: QUINAPRIL — Original Application (Aurobindo Pharma Limited)

  FDA approves the original generic application for quinapril hydrochloride (quinapril HCl) from Aurobindo Pharma Limited.

• FDA approval · 2013-04-04
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  The FDA approved a supplemental application for clopidogrel bisulfate submitted by Dr. Reddy's Laboratories Inc, for their generic clopidogr…

• FDA approval · 2013-03-18
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2013-03-14
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

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

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• FDA approval · 2013-03-05
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc, indicating an update to the drug'…

• FDA approval · 2013-02-20
  FDA Approved: LISINOPRIL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for lisinopril (Actavis Pharma, Inc.).

• FDA approval · 2013-02-01
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter's Supplemental Application for Nitroglycerin in Dextrose, adding this intravenous nitroglycerin formulation to the appro…

• FDA approval · 2012-12-17
  FDA Approved: QUINAPRIL — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for Quinapril from Cipla USA Inc., marking an additional regulatory action for this ACE inhibito…

• FDA approval · 2012-12-05
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Brilinta (ticagrelor) from AstraZeneca Pharmaceuticals LP. This action approves changes to Brili…

• FDA approval · 2012-08-13
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Zestril (lisinopril) submitted by Upsher-Smith Laboratories.

• FDA approval · 2012-06-06
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc.

• FDA approval · 2012-06-06
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc., resulting in labeling updates fo…

• FDA approval · 2012-05-17
  FDA Approved: CLOPIDOGREL BISULFATE — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' clopidogrel bisulfate as an original application (ANDA), enabling a generic version of the antiplatel…

• FDA approval · 2012-05-17
  FDA Approved: CLOPIDOGREL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic clopidogrel; an antiplatelet agent used to reduce cardiovascular events in patients with acute coronary syndrome…

• FDA approval · 2012-05-17
  FDA Approved: CLOPIDOGREL — Original Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's Original Application for clopidogrel bisulfate, enabling a generic version of clopidogrel to be mark…

• FDA approval · 2012-04-18
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approval of a supplemental application for clopidogrel bisulfate submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2012-03-29
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Zestril (lisinopril) submitted by Upsher-Smith Laboratories.

• FDA approval · 2012-03-23
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EFFIENT (prasugrel hydrochloride) filed by Cosette Pharmaceuticals, Inc.

• FDA approval · 2012-01-23
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for carvedilol, a generic beta-blocker, for a new or expanded generic…

• FDA approval · 2012-01-17
  FDA Approved: ATENOLOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for atenolol from Aurobindo Pharma Limited, sanctioning a generic Atenolol product. This approva…

• FDA approval · 2011-12-23
  FDA Approved: HEPARIN SODIUM AND DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Heparin Sodium and Dextrose (Hospira, Inc.). The update concerns labeling/indications for this a…

• FDA approval · 2011-11-28
  FDA Approved: ATENOLOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for generic atenolol from Rising Pharma Holdings, Inc. under the ANDA.

• FDA approval · 2011-10-25
  FDA Approved: ATENOLOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Atenolol from Teva Pharmaceuticals USA, Inc. This action updates the regulatory status of the ge…

• FDA approval · 2011-10-18
  FDA Approved: ATENOLOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for atenolol submitted by Aurobindo Pharma Limited, granting regulatory approval for the supplem…