Coronary Syndrome

• FDA approval · 2023-05-01
  FDA Approved: TIROFIBAN — Original Application (Eugia US LLC)

  The FDA approved Eugia US LLC's original Abbreviated New Drug Application for tirofiban, granting approval of a generic version of the anti-…

• FDA approval · 2023-04-21
  FDA Approved: TICAGRELOR — Original Application (Ascend Laboratories, LLC)

  FDA approved Ticagrelor under an Original Application by Ascend Laboratories, LLC. The approval supports its use as an antiplatelet therapy …

• FDA approval · 2023-04-12
  FDA Approved: PRASUGREL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for the generic prasugrel from Accord Healthcare Inc., finalizing a regulatory action under the ANDA…

• FDA approval · 2023-02-23
  FDA Approved: EPTIFIBATIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for the generic Eptifibatide from Mylan Institutional LLC. The approval updates the product's regula…

• FDA approval · 2023-02-07
  FDA Approved: TIROFIBAN HYDROCHLORIDE — Original Application (Nexus Pharmaceuticals LLC)

  FDA approved the original ANDA for tirofiban hydrochloride from Nexus Pharmaceuticals LLC.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2022-11-15
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Amphastar Pharmaceuticals, Inc.)

  FDA approves Amphastar Pharmaceuticals' supplemental application for enoxaparin sodium.

• 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 · 2022-03-31
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for clopidogrel bisulfate (Radha Pharmaceuticals, Inc.) under an ANDA, confirming its status as a ge…

• FDA approval · 2022-02-15
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for Heparin Sodium submitted by Sandoz Inc., indicating an additional regulatory action on this gene…

• FDA approval · 2022-02-14
  FDA Approved: PRASUGREL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for prasugrel from Aurobindo Pharma Limited, enabling a generic version of the antiplatelet drug…

• FDA approval · 2022-02-04
  FDA Approved: PRASUGREL — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application from Amneal Pharmaceuticals LLC for a generic prasugrel product.

• FDA approval · 2022-01-12
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for HEPARIN SODIUM from Sagent Pharmaceuticals, authorizing changes under an approved supplemental f…

• FDA approval · 2022-01-12
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for Heparin Sodium from Sagent Pharmaceuticals, confirming regulatory status and updates related to …

• FDA approval · 2021-09-07
  FDA Approved: EPTIFIBATIDE — Original Application (Hainan Shuangcheng Pharmaceuticals Co., Ltd.)

  The FDA approved the original ANDA for Eptifibatide from Hainan Shuangcheng Pharmaceuticals Co., Ltd., authorizing a generic version of the …

• FDA approval · 2021-07-09
  FDA Approved: TICAGRELOR — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves Mylan's generic ticagrelor under ANDA 208597.

• FDA approval · 2021-05-28
  FDA Approved: BIVALIRUDIN — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved the original application for a generic Bivalirudin product from Slate Run Pharmaceuticals, LLC.

• FDA approval · 2021-04-14
  FDA Approved: BIVALIRUDIN — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for the generic anticoagulant Bivalirudin from Fresenius Kabi USA, LLC.

• FDA approval · 2021-04-08
  FDA Approved: TIROFIBAN HYDROCHLORIDE — Original Application (Gland Pharma Limited)

  FDA approves the original ANDA for tirofiban hydrochloride from Gland Pharma Limited, establishing a generic tirofiban product.

• FDA approval · 2021-02-17
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2020-12-29
  FDA Approved: HEPARIN SODIUM — Original Application (BE Pharmaceuticals Inc.)

  FDA approved the original ANDA for Heparin Sodium from BE Pharmaceuticals Inc., providing a generic version of heparin for anticoagulation.

• FDA approval · 2020-12-29
  FDA Approved: HEPARIN SODIUM — Original Application (BE Pharmaceuticals Inc.)

  The FDA approved BE Pharmaceuticals Inc.'s original application for Heparin Sodium (a generic anticoagulant). It is used to prevent and trea…

• FDA approval · 2020-12-22
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2020-12-11
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

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

• FDA approval · 2020-09-15
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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