Stroke

• FDA approval · 2019-05-07
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Losartan Potassium from Unichem Pharmaceuticals (USA), Inc., authorizing the marketing of a gene…

• FDA approval · 2019-04-03
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for clopidogrel bisulfate from Aurobindo Pharma Limited, confirming regulatory approval for this gen…

• FDA approval · 2019-03-10
  FDA Approved: ASPIRIN AND DIPYRIDAMOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)

  The FDA approved a supplemental application for aspirin and dipyridamole (Dr. Reddy's Laboratories) to update/expand the product labeling fo…

• FDA approval · 2018-09-19
  FDA Approved: CERETEC — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approved a supplemental application for CERETEC (technetium-99m exametazime), a radiopharmaceutical imaging agent, to modify/expand its …

• EMA approval · 2018-08-01
  EMA Authorised: Clopidogrel HCS (clopidogrel (as hydrochloride)) — HCS bvba

  The EMA authorised Clopidogrel HCS (clopidogrel hydrochloride) for several cardiovascular indications including peripheral vascular diseases…

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• FDA approval · 2018-05-25
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Plavix (clopidogrel) submitted by Sanofi-Aventis U.S. LLC. The approval indicates regulatory…

• FDA approval · 2017-10-31
  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. The approval concerns changes to the …

• FDA approval · 2017-07-10
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Plavix (clopidogrel) by Sanofi-Aventis U.S. LLC, resulting in changes to the product labeling.

• FDA approval · 2017-01-18
  FDA Approved: ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE CAPSULES, 25 MG / 200 MG — Original Application (Endo USA, Inc.)

  FDA approves Endo USA's aspirin and extended-release dipyridamole capsules (25 mg/200 mg) for reducing the risk of stroke in patients who ha…

• FDA approval · 2016-06-09
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Losartan Potassium (generic) from Lupin Pharmaceuticals, Inc.

• FDA approval · 2016-05-11
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  The FDA approved a supplemental application filed by Dr. Reddy's Laboratories Inc for clopidogrel bisulfate (generic) to support changes to …

• FDA approval · 2016-05-11
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for CLOPIDOGREL BISULFATE submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2016-05-10
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for clopidogrel bisulfate (generic clopidogrel) from Radha Pharmaceuticals, Inc., indicating approva…

• FDA approval · 2016-03-08
  FDA Approved: ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE — Original Application (AvKARE)

  The FDA approved AvKARE's aspirin and extended-release dipyridamole as an original-application product (ANDA). It is indicated to reduce the…

• FDA approval · 2015-10-26
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for losartan potassium from Alembic Pharmaceuticals Limited under the ANDA.

• 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 · 2015-06-24
  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 · 2015-04-10
  FDA Approved: LOSARTAN POTASSIUM TABLETS, 25 MG — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a supplemental application for Jubilant Cadista's Losartan Potassium Tablets, 25 mg, supporting the approval of this generic do…

• 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 · 2015-02-13
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for Losartan Potassium from Solco Healthcare US, LLC.

• FDA approval · 2014-09-21
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Losartan Potassium from Quallent Pharmaceuticals Health LLC to update the approved generic p…

• FDA approval · 2014-09-15
  FDA Approved: CLOPIDOGREL BISULFATE — Original Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved the original ANDA for clopidogrel bisulfate, a generic antiplatelet agent, expanding access to a therapy that reduces vascular …

• FDA approval · 2014-07-28
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for the fixed-dose combination of amlodipine and atorvastatin (amlodipi…

• FDA approval · 2014-06-12
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Limited. This action confirms approval of th…