Pneumocystis Jirovecii Pneumonia

• FDA approval · 2015-07-09
  FDA Approved: DAPSONE — Supplemental Application (Pacific Pharma, Inc.)

  The FDA approved a supplemental application for DAPSONE submitted by Pacific Pharma, Inc.

• FDA approval · 2015-06-04
  FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Mepron (atovaquone) from GlaxoSmithKline LLC.

• FDA approval · 2014-12-21
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for sulfamethoxazole and trimethoprim from Amneal Pharmaceuticals of New York LLC. The approval cove…

• FDA approval · 2014-03-18
  FDA Approved: ATOVAQUONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's original ANDA for ATOVAQUONE, providing a generic option for Pneumocystis jirovecii pneumonia prop…

• FDA approval · 2013-10-03
  FDA Approved: DAPSONE — Supplemental Application (Pacific Pharma, Inc.)

  The FDA approved a supplemental application for Dapsone from Pacific Pharma, Inc., resulting in changes to the product labeling under the su…

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• FDA approval · 2013-03-01
  FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for MEPRON (atovaquone) from GlaxoSmithKline LLC.

• FDA approval · 2013-02-16
  FDA Approved: NEBUPENT — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for NebuPent (pentamidine isethionate) by Fresenius Kabi USA, LLC, to modify the existing approv…

• FDA approval · 2011-02-08
  FDA Approved: NEBUPENT — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for NEBUPENT (pentamidine isethionate) submitted by Fresenius Kabi USA, LLC. Nebupent is used to…

• FDA approval · 2010-02-16
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s generic product Sulfamethoxazole and Trimethoprim as an Original Application (ANDA).