Infective Endocarditis

• FDA approval · 2024-11-21
  FDA Approved: DAPTOMYCIN — Original Application (Par Health USA, LLC)

  FDA approves the original application for daptomycin by Par Health USA, LLC, authorizing its use as an antibiotic for certain serious infect…

• FDA approval · 2024-08-29
  FDA Approved: DAPTOMYCIN — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s original application for daptomycin (DAPTOMYCIN), a generic antibiotic.

• FDA approval · 2024-04-05
  FDA Approved: DAPTOMYCIN — Supplemental Application (BE Pharmaceuticals Inc.)

  The FDA approves BE Pharmaceuticals Inc.'s supplemental application for daptomycin. This action updates the regulatory status for the drug u…

• FDA approval · 2023-08-07
  FDA Approved: DAPTOMYCIN — Original Application (Mylan Institutional LLC)

  FDA approves a generic version of daptomycin under an Original Application (ANDA) from Mylan Institutional LLC.

• FDA approval · 2023-02-27
  FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Daptomycin in Sodium Chloride from Baxter, authorizing a saline formulation of the antibiotic.

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• FDA approval · 2022-12-23
  FDA Approved: DAPTOMYCIN — Original Application (NorthStar RxLLC)

  FDA approves NorthStar RxLLC's generic daptomycin (DAPTOMYCIN) under an Original ANDA. The approval confirms the generic's indication for us…

• FDA approval · 2022-11-13
  FDA Approved: DAPTOMYCIN — Supplemental Application (BE Pharmaceuticals Inc.)

  FDA approved a supplemental application for DAPTOMYCIN filed by BE Pharmaceuticals Inc. The approval relates to an ANDA and updates the regu…

• FDA approval · 2022-09-23
  FDA Approved: DAPTOMYCIN — Original Application (NorthStar RxLLC)

  The FDA approved the original application for daptomycin (generic) submitted by NorthStar RxLLC.

• FDA approval · 2021-09-02
  FDA Approved: DAPTOMYCIN — Original Application (Eugia US LLC)

  FDA approved the original application for daptomycin for Eugia US LLC, authorizing clearance of a generic daptomycin product.

• 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 · 2021-06-29
  FDA Approved: DAPTOMYCIN — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic daptomycin (daptomycin) under an original ANDA (ANDA 213623), authorizing its marketing a…

• FDA approval · 2021-05-05
  FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)

  The FDA approved a supplemental application for Civica, Inc.'s daptomycin. This action approves an update requested in the supplemental subm…

• FDA approval · 2020-09-09
  FDA Approved: DAPTOMYCIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for daptomycin (Hikma Pharmaceuticals USA Inc.), covering an additional formulation/strength under a…

• 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 · 2019-10-03
  FDA Approved: DAPTOMYCIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for daptomycin from Hikma Pharmaceuticals USA Inc. under ANDA206005. This represents a supplemen…

• FDA approval · 2019-09-18
  FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Daptomycin from Civica, Inc., approving an update to its labeling or indication.

• FDA approval · 2019-07-12
  FDA Approved: DAPTOMYCIN — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s original application for daptomycin (generic), authorizing a generic version of the antibiotic.

• FDA approval · 2019-06-26
  FDA Approved: DAPTOMYCIN — Original Application (BE Pharmaceuticals Inc.)

  FDA approved BE Pharmaceuticals Inc.'s original application for daptomycin, enabling the generic version of this antibiotic.

• FDA approval · 2019-06-24
  FDA Approved: DAPTOMYCIN — Original Application (Accord Healthcare Inc.)

  FDA approves the original application for Daptomycin (generic) from Accord Healthcare Inc., authorizing its commercialization as a generic a…

• FDA approval · 2018-06-05
  FDA Approved: DAPTOMYCIN — Original Application (Mylan Institutional LLC)

  FDA approved a generic daptomycin product from Mylan Institutional LLC via an Original Application. This approval provides a non-brand versi…

• 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…

• FDA approval · 2016-06-15
  FDA Approved: DAPTOMYCIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original application for daptomycin, a bacterial antibiotic, as a generic version manufactured by Hikma Pharmaceuticals USA…