Hypertension

• FDA approval · 2014-04-30
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Cardene IV (nicardipine hydrochloride) submitted by Baxter Healthcare Corporation.

• FDA approval · 2014-04-23
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Diovan HCT (valsartan and hydrochlorothiazide) from Novartis Pharmaceuticals Corporation, updati…

• FDA approval · 2014-04-23
  FDA Approved: SPIRONOLACTONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved the original ANDA for spironolactone, authorizing a generic version manufactured by Jubilant Cadista Pharmaceuticals Inc.

• FDA approval · 2014-04-21
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the combination product amlodipine besylate and atorvastatin calcium from Prasco Laboratories.

• FDA approval · 2014-04-18
  FDA Approved: EDARBYCLOR — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  The FDA approved a supplemental application for EDARBYCLOR (azilsartan medoxomil and chlorthalidone) submitted by Azurity Pharmaceuticals, l…

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• FDA approval · 2014-04-18
  FDA Approved: EDARBI — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EDARBI (azilsartan medoxomil) submitted by Azurity Pharmaceuticals, Inc.

• FDA approval · 2014-04-03
  FDA Approved: NIFEDIPINE — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories' original ANDA for a generic nifedipine product.

• FDA approval · 2014-03-26
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Losartan Potassium submitted by Lupin Pharmaceuticals, Inc., under an ANDA.

• FDA approval · 2014-03-23
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for enalapril maleate and hydrochlorothiazide from Dr. Reddy's Laboratories Limited, expanding regul…

• FDA approval · 2014-03-18
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for aliskiren hemifumarate from Prasco Laboratories, authorizing the drug to be marketed under this …

• FDA approval · 2014-03-17
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for DIOVAN HCT (valsartan/hydrochlorothiazide) from Novartis Pharmaceuticals Corporation. The action…

• FDA approval · 2014-03-17
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA has approved a supplemental application for EXFORGE, the fixed-dose combination of amlodipine besylate and valsartan, submitted by N…

• FDA approval · 2014-03-17
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for EXFORGE HCT, a fixed-dose triple combination of amlodipine, valsartan, and hydrochlorothiazi…

• FDA approval · 2014-03-07
  FDA Approved: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approved the original application for a generic fixed-dose combination of amlodipine besylate and atorvastatin calcium from Dr. Reddy's …

• FDA approval · 2014-03-06
  FDA Approved: SPIRONOLACTONE — Original Application (NorthStar Rx LLC)

  The FDA approved NorthStar Rx LLC's Original Application for spironolactone (generic spironolactone).

• FDA approval · 2014-02-28
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for a generic lisinopril and hydrochlorothiazide combination product from Lupin Pharmaceuticals, int…

• FDA approval · 2014-02-26
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (GSMS, Incorporated)

  FDA approved a supplemental application for the generic fixed-dose combination of lisinopril and hydrochlorothiazide (GSMS, Incorporated).

• FDA approval · 2014-02-26
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic lisinopril and hydrochlorothiazide combination tablet from Aurobindo Pharma Limited.

• FDA approval · 2014-02-26
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for a generic lisinopril and hydrochlorothiazide combination tablet.

• FDA approval · 2014-02-25
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved an original application for a generic fixed-dose combination of telmisartan and hydrochlorothiazide by Alembic Pharmaceuticals …

• FDA approval · 2014-02-19
  FDA Approved: GUANFACINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application to authorize a generic guanfacine hydrochloride product from Amneal Pharmaceuticals of New York LLC.…

• FDA approval · 2014-01-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for METOPROLOL SUCCINATE submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2014-01-27
  FDA Approved: FUROSEMIDE — Original Application (Civica, Inc.)

  FDA approves Civica, Inc.’s original application for furosemide (generic diuretic).

• FDA approval · 2014-01-23
  FDA Approved: FELODIPINE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for felodipine from Endo USA, Inc. under the approved ANDA.

• FDA approval · 2014-01-22
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for Hydrochlorothiazide submitted by Aurobindo Pharma Limited under an Abbreviated New Drug Applicat…