Peripheral Artery Disease

• EMA approval · 2025-11-05
  EMA Authorised: Rivaroxaban Viatris (previously Rivaroxaban Mylan) (rivaroxaban) — Viatris Limited

  The EMA authorised Viatris Limited to market rivaroxaban (brand name Rivaroxaban Viatris), expanding access to this anticoagulant as a gener…

• FDA approval · 2025-08-01
  FDA Approved: CLOPIDOGREL — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for clopidogrel from Amneal Pharmaceuticals LLC under the ANDA process (generic product).

• FDA approval · 2025-05-15
  FDA Approved: RIVAROXABAN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for generic rivaroxaban, a direct oral anticoagulant.

• EMA approval · 2025-05-14
  EMA Authorised: Clopidogrel Krka (clopidogrel (as hydrochloride)) — Krka, d.d., Novo mesto

  EMA authorised Clopidogrel Krka (clopidogrel hydrochloride) on 14 May 2025 for reducing cardiovascular events in patients with peripheral ar…

• FDA approval · 2025-02-25
  FDA Approved: CLOPIDOGREL — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for clopidogrel filed by NorthStar RxLLC under an ANDA. The action indicates regulatory clearance fo…

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• FDA approval · 2023-06-08
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for a generic clopidogrel product from Aurobindo Pharma Limited.

• FDA approval · 2022-09-16
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approves a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Inc, pertaining to the approved generic prod…

• FDA approval · 2022-09-12
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries’ supplemental application for clopidogrel bisulfate, indicating regulatory approval of change…

• FDA approval · 2021-12-21
  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. The action confirms approva…

• FDA approval · 2020-11-16
  FDA Approved: CILOSTAZOL — Supplemental Application (Apotex Corp.)

  FDA approves a supplemental application for Cilostazol submitted by Apotex Corp., updating the drug's approval status.

• FDA approval · 2020-07-17
  FDA Approved: CLOPIDOGREL — Original Application (POLYGEN PHARMACEUTICALS INC.)

  FDA approves Polygen Pharmaceuticals' original ANDA for a generic clopidogrel product.

• FDA approval · 2019-11-06
  FDA Approved: CLOPIDOGREL — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for clopidogrel under ANDA090844, finalizing an approval for its gen…

• FDA approval · 2019-09-20
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for clopidogrel bisulfate manufactured by Aurobindo Pharma Limited, enabling continued marketing…

• FDA approval · 2019-08-07
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  The FDA approved a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Inc, indicating a supplemental approval …

• FDA approval · 2019-08-02
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' supplemental application for clopidogrel bisulfate, approving changes to the product's labeling.

• FDA approval · 2019-08-02
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for clopidogrel bisulfate by Sun Pharmaceutical Industries, Inc. The approval covers the generic…

• 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 · 2017-12-01
  FDA Approved: CILOSTAZOL — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for cilostazol submitted by Chartwell RX, LLC.

• 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 · 2016-05-10
  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 · 2016-04-04
  FDA Approved: CILOSTAZOL — Supplemental Application (Apotex Corp.)

  The FDA approval of a supplemental application for cilostazol from Apotex Corp., enabling continued generic supply under the approved scope.

• FDA approval · 2016-04-04
  FDA Approved: CILOSTAZOL — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Cilostazol from Chartwell RX, LLC under an ANDA.

• FDA approval · 2016-04-04
  FDA Approved: CILOSTAZOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Cilostazol submitted by Teva Pharmaceuticals USA, Inc. This action updates the regulatory status…

• 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 · 2014-11-06
  FDA Approved: CILOSTAZOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for cilostazol submitted by Teva Pharmaceuticals USA, Inc., resulting in changes to the drug's l…