Pneumocystis Jirovecii Pneumonia

• FDA approval · 2026-03-20
  FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved GlaxoSmithKline's supplemental application for Mepron (atovaquone). It updates the drug's labeling and indications under ND…

• FDA approval · 2026-02-26
  FDA Approved: DAPSONE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved DAPSONE through an Original Application (ANDA) by Viona Pharmaceuticals Inc. The approval covers the generic use of DAPSONE for…

• FDA approval · 2025-06-17
  FDA Approved: DAPSONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for DAPSONE submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2025-04-23
  FDA Approved: DAPSONE — Supplemental Application (Seton Pharmaceuticals)

  FDA approved a supplemental application for DAPSONE tablets from Seton Pharmaceuticals.

• FDA approval · 2025-02-21
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for sulfamethoxazole and trimethoprim, granting approval of a generic p…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-06-24
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for sulfamethoxazole and trimethoprim by Prasco Laboratories. This action confirms the approval of t…

• FDA approval · 2024-04-02
  FDA Approved: ATOVAQUONE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for atovaquone.

• FDA approval · 2023-10-27
  FDA Approved: DAPSONE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved the original application for DAPSONE (dapsone) as a generic drug from Alembic Pharmaceuticals Inc.

• FDA approval · 2023-05-31
  FDA Approved: DAPSONE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the Original Application for Dapsone (DAPSONE) by Amneal Pharmaceuticals NY LLC, authorizing a generic version of the drug.

• FDA approval · 2022-11-22
  FDA Approved: ATOVAQUONE ORAL SUSPENSION — Supplemental Application (KVK-Tech, Inc.)

  FDA approved a supplemental application to authorize the Atovaquone oral suspension produced by KVK-Tech, Inc.

• FDA approval · 2022-03-17
  FDA Approved: PENTAMIDINE ISETHIONATE — Original Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approved the original application for Pentamidine isethionate (generic) from XGen Pharmaceuticals DJB, Inc., authorizing its U.S. market…

• FDA approval · 2022-02-10
  FDA Approved: DAPSONE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved the original application for DAPSONE (dapsone) as a generic drug manufactured by Torrent Pharmaceuticals Limited.

• FDA approval · 2021-10-25
  FDA Approved: ATOVAQUONE — Original Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved the original application for atovaquone, including the oral suspension, from PAI Holdings, LLC dba PAI Pharma, marking approval…

• FDA approval · 2021-03-30
  FDA Approved: ATOVAQUONE — Original Application (Bionpharma Inc.)

  FDA approved the original ANDA for atovaquone by Bionpharma Inc., authorizing a generic version of the medication.

• FDA approval · 2021-01-07
  FDA Approved: PENTAMIDINE ISETHIONATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approves an Original Application for Pentamidine isethionate injection as a generic product from Heritage Pharmaceuticals (Avet) Inc.

• FDA approval · 2020-07-28
  FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) filed by Sun Pharmaceutical Industries, Inc. to upda…

• FDA approval · 2019-11-07
  FDA Approved: ATOVAQUONE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for atovaquone submitted by Chartwell Governmental & Specialty RX, LLC.

• FDA approval · 2019-05-31
  FDA Approved: ATOVAQUONE ORAL SUSPENSION — Original Application (KVK-Tech, Inc.)

  FDA approved a generic version of atovaquone oral suspension (KVK-Tech, Inc.) via Original Application (ANDA210510).

• FDA approval · 2019-04-24
  FDA Approved: PENTAMIDINE ISETHIONATE — Original Application (Seton Pharmaceuticals)

  FDA approved pentamidine isethionate in an Original Application by Seton Pharmaceuticals. It is indicated for Pneumocystis jirovecii pneumon…

• FDA approval · 2019-02-22
  FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Mepron (atovaquone) submitted by GlaxoSmithKline LLC. The action updates the drug's labeling/ind…

• FDA approval · 2018-11-21
  FDA Approved: ATOVAQUONE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original application for atovaquone as a generic drug, confirming its approved uses for Pneumocystis jirovecii pneumonia, p…

• FDA approval · 2018-10-11
  FDA Approved: ATOVAQUONE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic atovaquone under an original ANDA (ANDA 210692).

• FDA approval · 2017-10-16
  FDA Approved: DAPSONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic version of dapsone (DAPSONE) through an original ANDA. The approval authorizes the sale …

• FDA approval · 2016-12-01
  FDA Approved: DAPSONE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' generic DAPSONE (dapsone) under an Original Application (ANDA206505).

• FDA approval · 2016-05-10
  FDA Approved: DAPSONE — Original Application (Chartwell RX, LLC)

  The FDA approved the original ANDA for DAPSONE from Chartwell RX, LLC.