Heart Failure

• FDA approval · 2020-12-10
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  The FDA approved a supplemental ANDA for Triamterene and Hydrochlorothiazide from Zydus Pharmaceuticals (USA) Inc., enabling the generic pro…

• FDA approval · 2020-12-02
  FDA Approved: METOLAZONE — Original Application (Alembic Pharmaceuticals Limited)

  Alembic Pharmaceuticals Limited's original application for metolazone received FDA approval, enabling the generic version to be marketed in …

• FDA approval · 2020-11-27
  FDA Approved: CHLORTHALIDONE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for a generic chlorthalidone product.

• FDA approval · 2020-11-25
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's metoprolol succinate extended-release tablets as an original application (generic).

• FDA approval · 2020-11-12
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Digoxin submitted by Amneal Pharmaceuticals of New York LLC.

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• FDA approval · 2020-11-06
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved a generic version of metoprolol succinate (Camber Pharmaceuticals) under an Original Application (ANDA 205541).

• FDA approval · 2020-10-07
  FDA Approved: DIGOXIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for digoxin filed by Sun Pharmaceutical Industries, Inc. to update the drug's labeling.

• FDA approval · 2020-10-07
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for digoxin submitted by Hikma Pharmaceuticals USA Inc., authorizing changes to the product as r…

• 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 · 2020-09-03
  FDA Approved: MILRINONE LACTATE — Original Application (Eugia US LLC)

  FDA approved Eugia US LLC's milrinone lactate injection in 5% dextrose as a generic injectable under an Original Application (ANDA 209666) f…

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Hydrochlorothiazide from Aurobindo Pharma Limited. The decision updates the approved generic pro…

• FDA approval · 2020-08-20
  FDA Approved: VASERETIC — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for VASERETIC (enalapril maleate and hydrochlorothiazide) from Bausch Health US, LLC.

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from Accord Healthcare Inc., approving changes under the supplemental submis…

• 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 · 2020-07-16
  FDA Approved: MILRINONE LACTATE IN DEXTROSE — Original Application (Hospira, Inc.)

  FDA approves the original Abbreviated New Drug Application for Milrinone lactate in dextrose injection from Hospira, a generic intravenous i…

• FDA approval · 2020-07-10
  FDA Approved: VALSARTAN — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for VALSARTAN by Solco Healthcare US, LLC.

• FDA approval · 2020-07-01
  FDA Approved: FUROSEMIDE — Original Application (Gland Pharma Limited)

  FDA approves the original generic application for furosemide from Gland Pharma Limited.

• FDA approval · 2020-06-11
  FDA Approved: SODIUM NITROPRUSSIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for a generic sodium nitroprusside product manufactured by Mylan Institutional LLC.

• FDA approval · 2020-05-31
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approves a supplemental ANDA for furosemide from Solco Healthcare LLC.

• FDA approval · 2020-05-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved Ipca Laboratories Limited's supplemental application for furosemide under an ANDA, updating the approved product.

• FDA approval · 2020-05-19
  FDA Approved: TOLVAPTAN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories LLC's original ANDA for tolvaptan, a vasopressin V2 receptor antagonist, as a generic option for treating h…

• FDA approval · 2020-05-05
  FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Farxiga (dapagliflozin) from AstraZeneca, adding/ updating labeling to reflect a new indication …

• FDA approval · 2020-05-05
  FDA Approved: VALSARTAN — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  The FDA approved Jubilant Cadista's supplemental application for the generic drug valsartan. Valsartan is used to treat hypertension, heart …

• FDA approval · 2020-05-04
  FDA Approved: TORSEMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Torsemide from Rising Pharma Holdings, Inc. under an ANDA (ANDA078249).