Candidiasis

• FDA approval · 2010-09-17
  FDA Approved: NIZORAL — Supplemental Application (Kramer Laboratories)

  FDA approved a supplemental application for NIZORAL (ketoconazole) from Kramer Laboratories, resulting in labeling updates for the product.

• FDA approval · 2010-03-05
  FDA Approved: AMPHOTERICIN B — Supplemental Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approved a supplemental application for Amphotericin B submitted by XGen Pharmaceuticals DJB, Inc. This approval authorizes a change to …

• FDA approval · 2009-12-03
  FDA Approved: NYSTATIN — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for NYSTATIN from Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2009-09-18
  FDA Approved: FLUCONAZOLE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for fluconazole from Rising Pharma Holdings, Inc., enabling the generic antifungal to enter the market…

• FDA approval · 2009-07-30
  FDA Approved: FLUCONAZOLE — Original Application (Hospira, Inc)

  FDA approved Hospira's original application for a generic fluconazole product, an antifungal medication with indications similar to the refe…

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• FDA approval · 2009-04-17
  FDA Approved: NYSTATIN — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for NYSTATIN submitted by Padagis Israel Pharmaceuticals Ltd. The action confirms approval of the su…

• FDA approval · 2007-09-10
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for clotrimazole by Padagis US LLC.

• FDA approval · 2007-09-04
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for a generic topical product combining nystatin and triamcinolone acetonide (Sun Pharmaceutical…

• FDA approval · 2007-04-30
  FDA Approved: BASIC CARE TIOCONAZOLE — Supplemental Application (Amazon.com Services LLC)

  FDA supplemental approval for Basic Care Tioconazole (tioconazole) to the Amazon.com Services LLC's ANDA075915 product, authorizing continue…

• FDA approval · 2006-09-15
  FDA Approved: NOXAFIL — Original Application (Merck Sharp & Dohme LLC)

  NOXAFIL (posaconazole) received FDA approval through its original application as a broad-spectrum antifungal agent for the prevention of inv…