Staphylococcus Aureus Bacteremia

• FDA approval · 2023-09-19
  FDA Approved: DAPTOMYCIN — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for daptomycin filed by Sagent Pharmaceuticals (ANDA 207104), resulting in an approved regulator…

• FDA approval · 2022-11-13
  FDA Approved: DAPTOMYCIN — Supplemental Application (APOTEX CORP.)

  FDA approved a supplemental application for Daptomycin from Apotex Corp. (ANDA 215316).

• FDA approval · 2021-08-24
  FDA Approved: DAPTOMYCIN — Original Application (APOTEX CORP.)

  FDA approved Apotex's Original Application for a generic version of daptomycin. The product is indicated for complicated skin and skin struc…

• FDA approval · 2020-08-20
  FDA Approved: DAPTOMYCIN — Original Application (BE Pharmaceuticals Inc.)

  The FDA approved BE Pharmaceuticals Inc.'s Original Application for Daptomycin (DAPTOMYCIN) as a generic antibiotic. The approval enables ge…

• FDA approval · 2019-11-15
  FDA Approved: DAPTOMYCIN — Original Application (Sagent Pharmaceuticals)

  FDA approved the original application for daptomycin by Sagent Pharmaceuticals, authorizing a generic injectable form of daptomycin.

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• FDA approval · 2019-08-22
  FDA Approved: DAPTOMYCIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic daptomycin under an Original Application. The approval covers the same indications as …

• FDA approval · 2017-09-12
  FDA Approved: DAPTOMYCIN — Original Application (Sagent Pharmaceuticals)

  FDA approval record for Daptomycin under an Original Application by Sagent Pharmaceuticals (NDA 208385). The entry documents FDA approval of…