Hypertension

• FDA approval · 2013-08-27
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from Macleods Pharmaceuticals Limited, authorizin…

• FDA approval · 2013-08-26
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved the supplemental application for amlodipine besylate from Lupin Pharmaceuticals, making its generic calcium channel blocker ava…

• FDA approval · 2013-08-16
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for generic lisinopril from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals), authorizing a cha…

• FDA approval · 2013-08-14
  FDA Approved: LISINOPRIL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for lisinopril from Actavis Pharma, Inc., authorizing the marketing of a generic lisinopril product.

• FDA approval · 2013-07-31
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the fixed-dose combination of amlodipine and atorvastatin, with Prasco Laboratories listed a…

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• FDA approval · 2013-07-29
  FDA Approved: EDARBI — Supplemental Application (Azurity Pharmaceuticals, Inc.)

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

• FDA approval · 2013-07-25
  FDA Approved: PROCARDIA XL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Procardia XL (nifedipine) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2013-07-09
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for amlodipine besylate, confirming the approval of the ANDA supplement for t…

• FDA approval · 2013-07-03
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Benicar (olmesartan medoxomil) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2013-07-03
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZOR (amlodipine besylate and olmesartan medoxomil) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2013-07-03
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TRIBENZOR, the triple combination antihypertensive (olmesartan medoxomil/amlodipine besylate…

• FDA approval · 2013-07-03
  FDA Approved: BENICAR HCT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Benicar HCT (olmesartan medoxomil–hydrochlorothiazide) from Cosette Pharmaceuticals, Inc., indic…

• FDA approval · 2013-06-13
  FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Method Pharmaceuticals, LLC)

  The FDA approved the original ANDA for clonidine hydrochloride tablets from Method Pharmaceuticals, LLC, establishing a generic version of c…

• FDA approval · 2013-06-12
  FDA Approved: ALDACTONE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Aldactone (spironolactone) from Pfizer. The approval updates the drug’s labeling.

• FDA approval · 2013-06-11
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Losartan Potassium submitted by Aurobindo Pharma Limited.

• FDA approval · 2013-06-10
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for losartan potassium by Alembic Pharmaceuticals Limited.

• FDA approval · 2013-06-10
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide, confirming approval of a generic combination product…

• FDA approval · 2013-05-28
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for the fixed-dose antihypertensive combination Losartan Potassium and Hydrochlorothiazide from …

• FDA approval · 2013-05-28
  FDA Approved: LOSARTAN POTASSIUM 25 MG — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for Losartan Potassium 25 mg (generic) by Strides Pharma Science Limited, enabling the generic p…

• FDA approval · 2013-05-28
  FDA Approved: METOPROLOL TARTRATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' metoprolol tartrate as an original generic product (ANDA 202871).

• FDA approval · 2013-05-14
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for carvedilol from Aurobindo Pharma Limited, granting approval of an additional generic carvedi…

• FDA approval · 2013-05-07
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for carvedilol from Dr. Reddy's Laboratories Limited (ANDA) to modify or update the approved product…

• FDA approval · 2013-05-07
  FDA Approved: CARVEDILOL — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for carvedilol submitted by Sandoz Inc.

• FDA approval · 2013-05-06
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Tribenzor, a fixed-dose combination of olmesartan medoxomil, amlodipine besylate, and hydrochlor…

• FDA approval · 2013-05-03
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's hydralazine hydrochloride as an original ANDA generic product for hypertension.