Clostridioides Difficile Infection

• FDA approval · 2012-12-19
  FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for DIFICID (fidaxomicin) submitted by Merck Sharp & Dohme LLC.

• 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 · 2011-05-27
  FDA Approved: DIFICID — Original Application (Merck Sharp & Dohme LLC)

  The FDA approved DIFICID (fidaxomicin) from Merck as the original application for the treatment of Clostridioides difficile infection. This …

• FDA approval · 2010-04-27
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Plano Pharmaceuticals Inc.)

  FDA approved Plano Pharmaceuticals Inc.'s original ANDA for vancomycin hydrochloride, granting generic approval for this injectable antibiot…

• FDA approval · 2009-08-06
  FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's supplemental application for metronidazole under NDA 018657.

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