Coronary Syndrome

• FDA approval · 2010-06-11
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Heparin Sodium from Fresenius Kabi USA, LLC.

• FDA approval · 2010-04-16
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2009-12-23
  FDA Approved: FRAGMIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Fragmin (dalteparin sodium) submitted by Pfizer Laboratories Div Pfizer Inc. The action indicate…

• FDA approval · 2009-07-10
  FDA Approved: EFFIENT — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' original application for prasugrel hydrochloride (Effient), a generic antiplatelet agent used to reduc…

• FDA approval · 2008-01-14
  FDA Approved: CLOPIDOGREL BISULFATE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's clopidogrel bisulfate tablet under an Original Application (ANDA076273). The approval enable…

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• FDA approval · 2007-12-14
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Civica, Inc.)

  FDA approved Civica, Inc.'s supplemental application for HEPARIN SODIUM. This action approves a supplemental NDA related to the product (NDA…

• FDA approval · 2007-10-22
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a supplemental application for Plavix (clopidogrel) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2007-09-20
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a supplemental application for PLAVIX (clopidogrel) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2007-01-12
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for ENOXAPARIN SODIUM submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2006-10-04
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Civica, Inc.)

  The FDA approved Civica, Inc.'s supplemental application for Heparin Sodium. This action updates the product labeling as part of the NDA 017…

• FDA approval · 2006-08-17
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Plavix (clopidogrel) submitted by Sanofi-Aventis U.S. LLC.