Leprosy

• 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 · 2025-04-04
  FDA Approved: DAPSONE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's Original Abbreviated New Drug Application for DAPSONE (dapsone), a generic antibiotic used for d…

• FDA approval · 2024-08-26
  FDA Approved: DAPSONE — Original Application (Trupharma, LLC)

  FDA approves a generic version of dapsone (DAPSONE) under Original Application by Trupharma, LLC (ANDA213636).

• FDA approval · 2024-05-08
  FDA Approved: DAPSONE — Original Application (Zydus Lifesciences Limited)

  FDA approves DAPSONE from Zydus Lifesciences Limited as an Original Application, providing a generic dapsone product.

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• 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 · 2023-10-19
  FDA Approved: DAPSONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the generic dapsone (DAPSONE) under Amneal Pharmaceuticals LLC's Original ANDA.

• 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 · 2022-02-04
  FDA Approved: DAPSONE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved an original application for DAPSONE from Mylan Pharmaceuticals, granting generic market authorization.

• FDA approval · 2021-09-14
  FDA Approved: RIFAMPIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Rifampin under the ANDA. The approval indicates changes to the Rifampin pro…

• FDA approval · 2019-05-08
  FDA Approved: DAPSONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves the Original Application for DAPSONE from Rising Pharma Holdings, Inc., enabling a generic version of the drug.

• 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.

• FDA approval · 2014-08-21
  FDA Approved: RIFAMPIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's generic rifampin (RIFAMPIN) under an Original Application (ANDA), expanding access to this antibiotic…

• FDA approval · 2008-05-22
  FDA Approved: RIFAMPIN — Original Application (Mylan Institutional LLC)

  FDA approved an Original Application for rifampin from Mylan Institutional LLC, enabling a generic rifampin product. This action approves th…

• FDA approval · 2008-03-28
  FDA Approved: RIFAMPIN — Original Application (Chartwell RX, LLC)

  FDA approved an Original Application (ANDA) for rifampin submitted by Chartwell RX, LLC. This marks approval of a generic rifampin product.