Edema

• FDA approval · 2020-12-10
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from BluePoint Laboratories.

• 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 · 2020-10-01
  FDA Approved: ACETAZOLAMIDE EXTENDED-RELEASE — Original Application (Micro Labs Limited)

  FDA approved an acetazolamide extended-release product as an original application from Micro Labs Limited.

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• 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: 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 · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from ScieGen Pharmaceuticals, Inc., under an ANDA.

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for HYDROCHLOROTHIAZIDE from Oxford Pharmaceuticals, LLC, authorizing regulatory approval for th…

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Leading Pharma, LLC)

  The FDA approved a supplemental application for hydrochlorothiazide submitted by Leading Pharma, LLC.

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from Actavis Pharma, Inc., indicating a regulatory action on this drug (such…

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Hydrochlorothiazide from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), authori…

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from Teva Pharmaceuticals USA, Inc., granting an update to the generic produ…

• FDA approval · 2020-08-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for HYDROCHLOROTHIAZIDE from Oxford Pharmaceuticals, LLC.

• FDA approval · 2020-07-29
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

• 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 · 2020-05-31
  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 · 2020-05-04
  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).

• FDA approval · 2020-04-06
  FDA Approved: BUMETANIDE — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for bumetanide (generic) under an ANDA.

• FDA approval · 2020-02-19
  FDA Approved: ETHACRYNIC ACID — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith's original generic application for Ethacrynic acid, a loop diuretic.

• FDA approval · 2019-12-12
  FDA Approved: BUMETANIDE — Original Application (Rising Pharma Holdings, Inc)

  FDA approved an original ANDA for bumetanide from Rising Pharma Holdings, Inc, making the generic diuretic available.

• FDA approval · 2019-11-14
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for spironolactone from Mylan Pharmaceuticals Inc., enabling continued marketing of the product and …

• FDA approval · 2019-11-14
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA has approved a supplemental application for spironolactone from Jubilant Cadista Pharmaceuticals Inc. under the ANDA framework.

• FDA approval · 2019-11-06
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application to allow Mylan Pharmaceuticals to market a generic spironolactone and hydrochlorothiazide combinatio…