Hypertension

• 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 · 2020-05-27
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for clonidine hydrochloride from Actavis Pharma, Inc. to bring a generic version of the antihype…

• FDA approval · 2020-05-21
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approved a supplemental application for clonidine hydrochloride from Somerset Therapeutics, LLC, under an ANDA, indicating approval of a…

• FDA approval · 2020-05-21
  FDA Approved: GUANFACINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA granted approval of a supplemental application for guanfacine from Actavis Pharma, enabling the generic version to be marketed. This…

• FDA approval · 2020-05-21
  FDA Approved: GUANFACINE — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved a supplemental application for guanfacine from Sun Pharmaceutical Industries (ANDA205689).

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• FDA approval · 2020-05-21
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for clonidine hydrochloride by Lupin Pharmaceuticals, Inc., under the ANDA framework.

• FDA approval · 2020-05-18
  FDA Approved: OLMESARTAN MEDOXOMIL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for olmesartan medoxomil tablets (generic olmesartan medoxomil) from Rising Pharma Holdings, Inc., for…

• FDA approval · 2020-05-14
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approved a supplemental application for verapamil hydrochloride, a generic version, filed by Somerset Therapeutics, LLC.

• 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 · 2020-04-29
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for lisinopril from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals, advancing an update to an e…

• FDA approval · 2020-04-29
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for diltiazem hydrochloride (generic) under ANDA074185.

• FDA approval · 2020-04-28
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's diltiazem hydrochloride as an original generic application (ANDA) for the established indications of diltia…

• FDA approval · 2020-04-27
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC, approving a generic lisinopril product.

• FDA approval · 2020-04-27
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for lisinopril submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2020-04-14
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for Enalapril Maleate and Hydrochlorothiazide from Taro Pharmaceuticals U.S.A., Inc., enabling a…

• FDA approval · 2020-04-14
  FDA Approved: TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application to authorize a fixed-dose combination of trandolapril and verapamil hydrochloride, submitted by …

• FDA approval · 2020-04-14
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Enalapril maleate from Northstar RxLLC under an ANDA.

• FDA approval · 2020-04-14
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for enalapril maleate (generic enalapril) submitted by Northstar RxLLC, effectively granting a suppl…

• FDA approval · 2020-04-13
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for a generic telmisartan and hydrochlorothiazide combination tablet for tr…

• FDA approval · 2020-04-10
  FDA Approved: TELMISARTAN — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for Telmisartan from Solco Healthcare US, LLC.

• FDA approval · 2020-03-31
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved an original ANDA for metoprolol succinate, a generic product manufactured by Nivagen Pharmaceuticals, Inc.

• FDA approval · 2020-03-27
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for verapamil hydrochloride from Nivagen Pharmaceuticals, Inc., updating regulatory status for this …

• FDA approval · 2020-03-25
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Caplin Steriles Limited)

  FDA approves Caplin Steriles Limited's Verapamil Hydrochloride under an Original Application (ANDA). This confirms the availability of a gen…

• FDA approval · 2020-03-16
  FDA Approved: AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic fixed-dose combination of amlodipine, valsartan, and hydrochlorothiazide manufactured …

• FDA approval · 2020-03-16
  FDA Approved: AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin's supplemental application for a generic fixed-dose combination of amlodipine, valsartan, and hydrochlorothiazide for the…