Angina Pectoris

• FDA approval · 2015-11-20
  FDA Approved: DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for diltiazem hydrochloride extended-release from Oceanside Pharmaceuticals.

• FDA approval · 2015-10-28
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (ACI Healthcare USA, Inc.)

  The FDA approved a supplemental application for amlodipine besylate from ACI Healthcare USA, Inc., effectively granting regulatory approval …

• FDA approval · 2015-10-26
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for verapamil hydrochloride (Actavis Pharma, Inc.), a generic product.

• FDA approval · 2015-10-14
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Verapamil Hydrochloride (generic) from Chartwell RX, LLC.

• FDA approval · 2015-10-02
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC.

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• FDA approval · 2015-10-02
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for amlodipine besylate as a generic product under an ANDA, expanding its availabilit…

• FDA approval · 2015-10-02
  FDA Approved: NIFEDIPINE — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for a nifedipine product from Leading Pharma, LLC, associated with an approved generic (ANDA074045).

• FDA approval · 2015-09-25
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (PD-Rx Pharmaceuticals, Inc.)

  FDA approved a supplemental application for amlodipine besylate by PD-Rx Pharmaceuticals, Inc. under ANDA 076719, allowing marketing of this…

• FDA approval · 2015-09-18
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for amlodipine besylate (generic amlodipine) under an ANDA, allowing the update…

• FDA approval · 2015-09-18
  FDA Approved: AMLODIPINE BESYLATE 2.5 MG — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application to add a 2.5 mg strength of amlodipine besylate for Oxford Pharmaceuticals’ generic product, expandi…

• FDA approval · 2015-09-16
  FDA Approved: NADOLOL — Original Application (Aurobindo Pharma Limited)

  FDA approved Nadolol tablets as a generic drug under an Original Application (ANDA 201893) from Aurobindo Pharma Limited. This approval make…

• FDA approval · 2015-09-10
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental application for TENORMIN (atenolol) submitted by Almatica Pharma LLC.

• FDA approval · 2015-09-08
  FDA Approved: NIFEDIPINE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved Oceanside Pharmaceuticals' supplemental application for nifedipine (ANDA075289), authorizing a modification to the approved gen…

• FDA approval · 2015-09-08
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Metoprolol Tartrate from Aurobindo Pharma Limited, a generic beta-blocker used in cardiovascular…

• FDA approval · 2015-08-25
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approves Apotex Corp.'s supplemental application for diltiazem hydrochloride (generic) under an abbreviated new drug application (ANDA).

• FDA approval · 2015-08-13
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for metoprolol tartrate from Fresenius Kabi USA, LLC.

• FDA approval · 2015-07-15
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for TENORMIN (atenolol) submitted by Almatica Pharma LLC, updating the drug’s labeling as part of a …

• FDA approval · 2015-07-09
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental NDA for Tenormin (atenolol) submitted by Almatica Pharma LLC, authorizing a supplemental labeling/indication…

• FDA approval · 2015-07-01
  FDA Approved: ATENOLOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Atenolol from Mylan Pharmaceuticals Inc., approving changes to the approved ANDA.

• FDA approval · 2015-06-17
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter's supplemental application for Nitroglycerin in Dextrose, approving a nitroglycerin-in-dextrose intravenous formulation …

• FDA approval · 2015-06-02
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for nicardipine hydrochloride from Civica, Inc., signaling regulatory approval of a supplement to th…

• FDA approval · 2015-03-23
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Norvasc (amlodipine besylate) submitted by Viatris Specialty LLC to update the labeling.

• FDA approval · 2015-03-20
  FDA Approved: ATENOLOL — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for Atenolol from Ipca Laboratories Limited under the ANDA, granting approval for changes related to…

• FDA approval · 2015-03-18
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for METOPROLOL TARTRATE by Mylan Pharmaceuticals Inc., confirming approval of the generic product.

• FDA approval · 2015-02-06
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for metoprolol tartrate submitted by Mylan Pharmaceuticals Inc.