Bacteremia

• 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 · 2019-06-12
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved the vancomycin hydrochloride original application for Slate Run Pharmaceuticals, enabling a generic version of this antibiotic.

• FDA approval · 2019-02-15
  FDA Approved: TYZAVAN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved TYZAVAN (vancomycin) from Hikma Pharmaceuticals USA Inc. under an Original Application (NDA211962). This marks the brand’s offi…

• 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…

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• FDA approval · 2018-04-05
  FDA Approved: NAFCILLIN — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Nafcillin submitted by Baxter Healthcare Corporation under NDA 050655.

• FDA approval · 2018-02-21
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (SAMSON MEDICAL TECHNOLOGIES LLC)

  The FDA approved Samson Medical Technologies LLC's supplemental application for vancomycin hydrochloride, a generic antibiotic, under an app…

• 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 · 2017-07-14
  FDA Approved: NAFCILLIN — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for naficillin submitted by Baxter Healthcare Corporation.

• 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…

• FDA approval · 2016-03-31
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Eugia US LLC)

  The FDA approved a generic vancomycin hydrochloride for injection under an original application from Eugia US LLC. This adds a generic IV op…

• FDA approval · 2012-04-09
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original ANDA for vancomycin hydrochloride from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., enabling a g…

• FDA approval · 2011-06-30
  FDA Approved: NAFCILLIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for Nafcillin sodium (NAFCILLIN SODIUM) as a generic injectable antibiotic from Fresenius Kabi USA, LL…

• FDA approval · 2011-04-20
  FDA Approved: NAFCILLIN — Original Application (Athenex Pharmaceutical Division, LLC.)

  FDA approves the original application for Nafcillin (nafcillin sodium) as a generic antibiotic from Athenex Pharmaceutical Division, LLC.