Oral Candidiasis

• FDA approval · 2021-08-10
  FDA Approved: NYSTATIN — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved Macleods Pharmaceuticals Limited's original application for NYSTATIN (Nystatin), a generic antifungal product. The approval…

• FDA approval · 2021-01-14
  FDA Approved: NYSTATIN — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved an Original Application for NyStatin (nystatin) by Macleods Pharmaceuticals Limited, establishing a generic antifungal product.…

• FDA approval · 2019-07-24
  FDA Approved: NYSTATIN — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved the Original Application for Nystatin from Torrent Pharmaceuticals Limited, authorizing a generic antifungal product.

• FDA approval · 2018-05-25
  FDA Approved: NYSTATIN — Original Application (Viona Pharmaceuticals Inc)

  FDA approved NYSTATIN as an Original Application (ANDA 207767) for a generic nystatin product by Viona Pharmaceuticals Inc.

• FDA approval · 2017-05-30
  FDA Approved: NYSTATIN — Original Application (Leading Pharma, LLC)

  FDA approved Leading Pharma, LLC's Original Application (ANDA208838) to market a generic nystatin product (Nystatin). This represents the fi…

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• FDA approval · 2016-08-25
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Foster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC))

  The FDA approved a supplemental application for clotrimazole, reflecting a regulatory update to its approval.

• FDA approval · 2016-01-07
  FDA Approved: NYSTATIN — Original Application (Pharmaceutical Associates, Inc.)

  FDA approved a generic Nystatin product from Pharmaceutical Associates, Inc. under an original application (ANDA).

• 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 · 2009-08-20
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for clotrimazole from Sun Pharmaceutical Industries, Inc., updating the approved product informa…

• 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 · 2008-09-02
  FDA Approved: CLOTRIMAZOLE — Original Application (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.)

  FDA approved the original application for clotrimazole as a generic product; the approval is held by E. Fougera & Co. a division of Fougera …

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

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