Myocardial Infarction

• FDA approval · 2021-12-23
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for lisinopril submitted by Camber Pharmaceuticals, Inc., approving changes to the lisinopril pr…

• 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 · 2021-12-06
  FDA Approved: VALSARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for valsartan submitted by Aurobindo Pharma Limited, updating the existing approval for this generic…

• FDA approval · 2021-12-06
  FDA Approved: VALSARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for VALSARTAN from Macleods Pharmaceuticals Limited. This approval supports continued distribution o…

• FDA approval · 2021-11-02
  FDA Approved: VALSARTAN — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original ANDA for valsartan, enabling generic manufacture and marketing of valsartan for its approved …

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• FDA approval · 2021-10-27
  FDA Approved: VALSARTAN — Original Application (ScieGen Pharmaceuticals, INC.)

  FDA approves the original application for VALSARTAN (Valsartan) from ScieGen Pharmaceuticals as a generic angiotensin II receptor blocker. I…

• FDA approval · 2021-10-25
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for metoprolol tartrate (generic beta-blocker), under an ANDA.

• FDA approval · 2021-10-05
  FDA Approved: VALSARTAN — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approves the original application for valsartan from Dr. Reddy's Laboratories Limited, granting approval for the generic product.

• FDA approval · 2021-10-01
  FDA Approved: RAMIPRIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Ramipril from Rising Pharma Holdings, Inc., enabling the continued manufacture and distribut…

• 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 · 2021-08-17
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for lisinopril from Camber Pharmaceuticals, Inc., for the generic product.

• FDA approval · 2021-08-05
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for enalaprilate maleate from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effecti…

• 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 · 2021-04-02
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for ramipril (generic ACE inhibitor), enabling continued marketing with the…

• FDA approval · 2021-04-02
  FDA Approved: RAMIPRIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Ramipril from Rising Pharma Holdings, Inc., indicating an updated approval under the ANDA.

• FDA approval · 2021-03-04
  FDA Approved: LISINOPRIL — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC’s original application for lisinopril, a generic ACE inhibitor. Lisinopril is used to treat hypertension, con…

• 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 · 2020-09-17
  FDA Approved: LISINOPRIL — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for lisinopril by Exelan Pharmaceuticals Inc., related to a generic lisinopril product. This ref…

• FDA approval · 2020-09-15
  FDA Approved: LISINOPRIL — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC's generic lisinopril (LISINOPRIL) under an original ANDA for the same indications as the brand. Indications i…

• FDA approval · 2020-07-24
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  The FDA approved a supplemental application for ramipril (generic ramipril) filed by Chartwell RX, LLC., under ANDA 078745.

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

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