Myocardial Infarction

• FDA approval · 2015-08-18
  FDA Approved: HEPARIN SODIUM IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter's Supplemental Application for Heparin Sodium in Sodium Chloride (Heparin Sodium), approving changes to an already-appro…

• FDA approval · 2015-08-13
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for metoprolol tartrate from Fresenius Kabi USA, LLC.

• FDA approval · 2015-07-28
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Inc, for a generic version of clopidogrel.

• FDA approval · 2015-07-16
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA lists a supplemental application for Plavix (clopidogrel) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2015-07-15
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for TENORMIN (atenolol) submitted by Almatica Pharma LLC, updating the drug’s labeling as part of a …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2015-07-09
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental NDA for Tenormin (atenolol) submitted by Almatica Pharma LLC, authorizing a supplemental labeling/indication…

• FDA approval · 2015-07-01
  FDA Approved: ATENOLOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Atenolol from Mylan Pharmaceuticals Inc., approving changes to the approved ANDA.

• FDA approval · 2015-06-24
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approves a supplemental application for Brilinta (ticagrelor) from AstraZeneca. The approval updates Brilinta's labeling as described in…

• FDA approval · 2015-06-09
  FDA Approved: VALSARTAN — Original Application (Solco Healthcare US, LLC)

  FDA approved the original ANDA for valsartan (generic) submitted by Solco Healthcare US, LLC, authorizing marketing of this ARB for hyperten…

• FDA approval · 2015-05-01
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for enalapril maleate from ScieGen Pharmaceuticals, indicating continued/expanded authorization …

• FDA approval · 2015-04-09
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for lisinopril filed by Quallent Pharmaceuticals Health LLC under ANDA 077321, enabling continued ma…

• FDA approval · 2015-03-26
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Brilinta (ticagrelor) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2015-03-20
  FDA Approved: ATENOLOL — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for Atenolol from Ipca Laboratories Limited under the ANDA, granting approval for changes related to…

• FDA approval · 2015-03-18
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for METOPROLOL TARTRATE by Mylan Pharmaceuticals Inc., confirming approval of the generic product.

• FDA approval · 2015-02-06
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for metoprolol tartrate submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2015-01-20
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA granted a supplemental approval for CAPTOPRIL (captopril) from Camber Pharmaceuticals, Inc., updating the labeling for an existing capto…

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an Abbreviated New Drug Application for valsartan by Mylan Pharmaceuticals, enabling a generic version of the drug.

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for valsartan, a generic ARB. The product is indicated for hypertension, heart fai…

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for valsartan, a generic ARB, for hypertension, heart failure, and reducing cardiov…

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Aurobindo Pharma Limited)

  FDA approves the Original Application for VALSARTAN from Aurobindo Pharma Limited, enabling the generic valsartan product to enter the marke…

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved Jubilant Cadista Pharmacuticals Inc.'s original ANDA for valsartan, a generic angiotensin II receptor blocker. The approval ena…

• FDA approval · 2014-12-19
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC under the ANDA. The action approves changes to the al…

• FDA approval · 2014-12-11
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril filed by Solco Healthcare U.S., LLC.

• FDA approval · 2014-12-05
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for captopril from Hikma Pharmaceuticals USA, documenting changes to the marketed captopril product …

• FDA approval · 2014-11-07
  FDA Approved: ATENOLOL — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for Atenolol from Ipca Laboratories Limited under an ANDA.