Cutaneous Candidiasis

• FDA approval · 2025-03-21
  FDA Approved: NYSTATIN — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic Nystatin product from Aurobindo Pharma Limited under an Original Application.

• FDA approval · 2023-10-16
  FDA Approved: CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% — Original Application (Allegis Holdings, LLC)

  The FDA approved Allegis Holdings' clotrimazole topical solution 1% under an Original Application (ANDA), making a generic clotrimazole topi…

• FDA approval · 2022-07-13
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original ANDA for Nystatin and Triamcinolone Acetonide (Macleods) for topical treatment of fungal skin infections with infl…

• FDA approval · 2021-08-17
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for a topical Nystatin and Triamcinolone Acetonide product from Macleods Pharmaceuticals Limited for t…

• 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…

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• FDA approval · 2021-05-20
  FDA Approved: KETOCONAZOLE — Original Application (Encube Ethicals, Inc.)

  FDA approves Encube Ethicals' ketoconazole cream, 2% as an original-application generic topical antifungal product (ANDA212443).

• 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 · 2020-07-14
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals' generic Nystatin and Triamcinolone Acetonide topical cream under an Original Application (ANDA 213142)…

• FDA approval · 2020-07-06
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (NORTHSTAR RX LLC)

  FDA approved a supplemental application for clotrimazole and betamethasone dipropionate topical from NorthStar RX LLC.

• FDA approval · 2020-05-29
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc. USA)

  FDA approved a supplemental application for clotrimazole and betamethasone dipropionate from Glenmark Pharmaceuticals USA, authorizing an up…

• FDA approval · 2019-07-25
  FDA Approved: CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% — Original Application (TruPharma LLC)

  FDA approved TruPharma LLC's clotrimazole topical solution 1% as an original application (ANDA) for treatment of common cutaneous fungal inf…

• 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 · 2018-11-08
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Viona Pharmaceuticals Inc)

  The FDA approved the original application for a generic topical cream containing nystatin and triamcinolone acetonide, manufactured by Viona…

• FDA approval · 2018-05-31
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves the original application for the generic topical combination Nystatin and Triamcinolone Acetonide by Lupin Pharmaceuticals for …

• 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 · 2018-05-21
  FDA Approved: NYSTATIN — Original Application (Leading Pharma, LLC)

  The FDA has approved an original ANDA for NYSTATIN from Leading Pharma, LLC.

• FDA approval · 2018-04-30
  FDA Approved: KLAYESTA — Original Application (Epic Pharma, LLC)

  FDA approved KLAYESTA, a nystatin topical powder, via an original ANDA from Epic Pharma, LLC.

• FDA approval · 2018-04-18
  FDA Approved: ECONAZOLE NITRATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for econazole nitrate from Aurobindo Pharma Limited, enabling a generic topical antifungal product.

• FDA approval · 2017-09-26
  FDA Approved: NYSTATIN CREAM — Original Application (Crown Laboratories)

  FDA approves Crown Laboratories' Nystatin Cream as an original generic topical antifungal (ANDA 207733) indicated for candidiasis, including…

• FDA approval · 2017-08-21
  FDA Approved: MICONAZOLE 3 — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for MICONAZOLE 3 (miconazole nitrate) by Rite Aid Corporation.

• FDA approval · 2017-08-14
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a generic Nystatin and Triamcinolone Acetonide Cream under an Original Application by Padagis Israel Pharmaceuticals Ltd. It is…

• FDA approval · 2017-06-08
  FDA Approved: NYSTATIN — Original Application (Zydus Lifesciences Limited)

  FDA approves the original application for Nystatin from Zydus Lifesciences Limited.

• 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 · 2016-06-23
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's generic Nystatin and Triamcinolone Acetonide topical ointment (ANDA 208300) for the treatment of cutaneous candidias…

• FDA approval · 2016-02-25
  FDA Approved: CICLOPIROX OLAMINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Ciclopirox olamine to update labeling and support use for common superficial fungal skin infecti…