Hypertensive Emergency

• FDA approval · 2021-07-12
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (BE Pharmaceuticals Inc.)

  FDA approved BE Pharmaceuticals Inc.'s original application for a generic sodium nitroprusside product.

• FDA approval · 2021-04-16
  FDA Approved: CLEVIPREX — Supplemental Application (Fresenius Kabi Austria GmbH)

  FDA approved a supplemental application for CLEVIPREX (clevidipine) from Fresenius Kabi Austria GmbH. The action involves a labeling/indicat…

• FDA approval · 2020-06-11
  FDA Approved: SODIUM NITROPRUSSIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for a generic sodium nitroprusside product manufactured by Mylan Institutional LLC.

• FDA approval · 2019-11-29
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' generic sodium nitroprusside under an Original Application (ANDA) for sale as a vasodilator to rapidl…

• FDA approval · 2018-08-17
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original ANDA for Sodium nitroprusside from Somerset Therapeutics, LLC, authorizing a generic IV vasodilator for use in hyp…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2018-04-17
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Mylan Institutional LLC)

  FDA approved the original application for sodium nitroprusside from Mylan Institutional LLC, introducing a generic version of this vasodilat…

• 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 …

• 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 · 2013-11-08
  FDA Approved: CLEVIPREX — Supplemental Application (Fresenius Kabi Austria GmbH)

  The FDA approved a supplemental application for CLEVIPREX (clevidipine), submitted by Fresenius Kabi Austria GmbH. The action is categorized…

• FDA approval · 2012-04-03
  FDA Approved: LABETALOL HYDROCHLORIDE — Original Application (Fosun Pharma USA Inc.)

  The FDA approved the original ANDA for labetalol hydrochloride (generic) by Fosun Pharma USA Inc., authorizing its marketing as a generic an…