Angina Pectoris

• FDA label_change · 2025-04-16
  FDA Approved: CARDIZEM CD — Supplemental Application (Bausch Health US LLC)

  FDA approves a supplemental application for Cardizem CD (diltiazem hydrochloride) by Bausch Health US LLC.

• FDA label_change · 2024-11-13
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Metoprolol Tartrate from Fresenius Kabi USA, LLC, indicating approved changes to labeling or for…

• FDA label_change · 2022-01-12
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) to update the labeling, submitted by Melinta Therapeutics, LLC.

• FDA label_change · 2021-09-15
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

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

• FDA label_change · 2019-08-07
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Bisoprolol Fumarate by Unichem Pharmaceuticals (USA), Inc., resulting in a labeling change for t…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA label_change · 2017-10-30
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA granted a supplemental approval for Norvasc (amlodipine besylate) filed by Viatris Specialty LLC, resulting in labeling changes.

• FDA label_change · 2017-01-31
  FDA Approved: NITROSTAT — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Nitrostat (nitroglycerin) from Viatris Specialty LLC, resulting in changes to the product la…

• FDA label_change · 2016-04-08
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (EXELA PHARMA SCIENCES, LLC)

  FDA approved a supplemental application for verapamil hydrochloride, resulting in changes to its labeling.

• FDA label_change · 2015-06-29
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for Bisoprolol Fumarate (Natco Pharma USA LLC), resulting in labeling changes for the product.

• FDA label_change · 2014-05-06
  FDA Approved: PROCARDIA XL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Procardia XL (nifedipine) from Pfizer Laboratories to update the product labeling.

• FDA label_change · 2014-05-06
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) filed by Melinta Therapeutics, resulting in labeling changes fo…

• FDA label_change · 2013-07-24
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Norvasc (amlodipine besylate) resulting in updates to the product labeling.

• FDA label_change · 2012-11-16
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for NORVASC (amlodipine besylate) filed by Viatris Specialty LLC.

• FDA label_change · 2011-05-09
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Norvasc (amlodipine besylate) filed by Viatris Specialty LLC. This action updates the produc…

• FDA label_change · 2007-10-31
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for NORVASC (amlodipine besylate) by Viatris Specialty LLC, resulting in changes to the labeling…

• FDA label_change · 2007-03-14
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• FDA label_change · 2007-02-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc., resulting in labe…