Hypertension

• FDA approval · 2018-01-26
  FDA Approved: KAPSPARGO — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved KAPSPARGO (metoprolol succinate) through an original new drug application by Sun Pharmaceutical Industries, marking regulatory …

• FDA approval · 2017-12-19
  FDA Approved: AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic fixed-dose combination tablet containing amlodipine, valsartan, and hydrochlorothiazide for hypertension. The approva…

• FDA approval · 2017-12-19
  FDA Approved: NIFEDIPINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for a generic nifedipine product by Zydus Lifesciences Limited. The approval covers nifedipine for the…

• FDA approval · 2017-12-13
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for diltiazem hydrochloride filed by Hospira, Inc., signaling an additional approval related to the …

• FDA approval · 2017-12-08
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's original ANDA for a generic sodium nitroprusside injection. Sodium nitroprusside is a vasodilator used to …

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• FDA approval · 2017-11-30
  FDA Approved: BYSTOLIC — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for BYSTOLIC (nebivolol hydrochloride) submitted by Allergan, Inc.

• FDA approval · 2017-11-27
  FDA Approved: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — Original Application (Zydus Lifesciences Limited)

  FDA approves Zydus Lifesciences' generic fixed-dose combination of candesartan cilexetil and hydrochlorothiazide for the treatment of hypert…

• FDA approval · 2017-11-20
  FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Xiamen LP Pharmaceutical Co., Ltd.)

  FDA approves the original application for clonidine hydrochloride from Xiamen LP Pharmaceutical Co., Ltd., granting a generic version of the…

• FDA approval · 2017-11-20
  FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (BluePoint Laboratories)

  FDA approved an original abbreviated new drug application for a generic clonidine hydrochloride product from BluePoint Laboratories.

• FDA approval · 2017-11-17
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for verapamil hydrochloride from Chartwell RX, LLC.

• FDA approval · 2017-11-14
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for ALISKIREN Hemifumarate (Prasco Laboratories).

• FDA approval · 2017-11-07
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's original application for a generic sodium nitroprusside product.

• FDA approval · 2017-11-06
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Solco Healthcare LLC)

  FDA approved a generic fixed-dose combination tablet of telmisartan and hydrochlorothiazide from Solco Healthcare LLC under an original ANDA…

• FDA approval · 2017-11-06
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Original Application (Solco Healthcare US, LLC)

  FDA approved the generic combination product Losartan Potassium and Hydrochlorothiazide from Solco Healthcare US, LLC under an original appl…

• FDA approval · 2017-11-02
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Original Application (Micro Labs Limited)

  FDA approves an original generic application for a fixed-dose combination tablet of amlodipine and olmesartan medoxomil by Micro Labs Limite…

• FDA approval · 2017-10-30
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a fixed-dose combination of amlodipine and atorvastatin, manufactured by Prasco Laboratories, en…

• FDA approval · 2017-10-25
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for a generic Losartan Potassium and Hydrochlorothiazide tablet from Lupin Pharmaceuticals, Inc. Thi…

• FDA approval · 2017-10-25
  FDA Approved: CARVEDILOL PHOSPHATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved an original-application generic product of carvedilol phosphate from Sun Pharmaceutical Industries.

• FDA approval · 2017-10-23
  FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' clonidine hydrochloride as an original ANDA, enabling a generic clonidine hydrochloride product to enter…

• FDA approval · 2017-10-03
  FDA Approved: TELMISARTAN — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's generic Telmisartan as an Original Application (ANDA) product, making a new generic version of telmisartan…

• FDA approval · 2017-09-29
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Losartan potassium and hydrochlorothiazide from Macleods Pharmaceuticals Limited.

• FDA approval · 2017-09-29
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  The FDA approved Jubilant Cadista's supplemental application for Losartan potassium and hydrochlorothiazide, a generic combination product u…

• FDA approval · 2017-09-29
  FDA Approved: DOXAZOSIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for doxazosin (doxazosin mesylate) under ANDA075536.

• FDA approval · 2017-09-22
  FDA Approved: INDAPAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Indapamide (ANI Pharmaceuticals), updating its regulatory approval.

• FDA approval · 2017-09-19
  FDA Approved: LABETALOL HYDROCHLORIDE — Original Application (BluePoint Laboratories Inc.)

  FDA approved an original application for labetalol hydrochloride from BluePoint Laboratories Inc., granting a generic version of the drug ma…