Seborrheic Dermatitis

• FDA approval · 2025-03-07
  FDA Approved: KETOCONAZOLE — Original Application (Viona Pharmaceuticals Inc)

  FDA approves the Original Application for Ketoconazole submitted by Viona Pharmaceuticals Inc, granting approval of a generic ketoconazole p…

• FDA approval · 2024-09-16
  FDA Approved: KETOCONAZOLE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' original application for a generic ketoconazole product.

• FDA approval · 2023-12-28
  FDA Approved: CLOBETASOL PROPIONATE ANDA — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved the original ANDA for clobetasol propionate topical from Macleods Pharmaceuticals Limited, enabling a generic version of th…

• FDA approval · 2020-08-27
  FDA Approved: HALOBETASOL PROPIONATE — Supplemental Application (Coral Way Pharma, LLC)

  FDA approved a supplemental application for halobetasol propionate filed by Coral Way Pharma, LLC.

• FDA approval · 2020-02-18
  FDA Approved: KETOCONAZOLE — Supplemental Application (THIRTY MADISON INC)

  The FDA approved a supplemental application for Ketoconazole filed by Thirty Madison Inc, resulting in updates to the Ketoconazole product l…

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• FDA approval · 2019-11-15
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Encube Ethicals, Inc.)

  FDA approved the Original Application for Clobetasol Propionate Ointment USP, 0.05% (generic) by Encube Ethicals, Inc.

• FDA approval · 2019-09-06
  FDA Approved: CLOBETASOL PROPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for clobetasol propionate from Sun Pharmaceutical Industries, enhancing its approval under the gener…

• FDA approval · 2019-02-13
  FDA Approved: FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% — Original Application (Encube Ethicals, Inc.)

  FDA approves Encube Ethicals' generic fluocinonide acetonide topical solution 0.01% (Original Application) for inflammatory and pruritic cor…

• FDA approval · 2018-06-18
  FDA Approved: KETOCONAZOLE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's original ANDA for Ketoconazole, a generic antifungal product, covering common dermatophytic an…

• FDA approval · 2018-04-17
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Xiromed, LLC)

  FDA approved the original application for clobetasol propionate (topical) by Xiromed, LLC. It is a potent corticosteroid indicated for corti…

• FDA approval · 2017-11-21
  FDA Approved: HYDROCORTISONE BUTYRATE — Original Application (The J. Molner Company LLC)

  The FDA approved a generic topical hydrocortisone butyrate product under an Original Application (ANDA 209556) from The J. Molner Company LL…

• FDA approval · 2017-03-20
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Northstar Rx LLC)

  FDA approved the original application for a generic clobetasol propionate topical corticosteroid, manufactured by Northstar Rx LLC. The appr…

• FDA approval · 2016-12-13
  FDA Approved: DERMOTIC — Supplemental Application (Royal Pharmaceuticals)

  The FDA approved a supplemental application for DERMOTIC (fluocinonide acetate) from Royal Pharmaceuticals.

• FDA approval · 2016-05-12
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Betamethasone Dipropionate from E. Fougera & Co., authorizing changes to the approved produc…

• FDA approval · 2016-04-25
  FDA Approved: FLUOCINOLONE ACETONIDE OIL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves Rising Pharma Holdings' Fluocinonide Acetonide Oil as a generic topical corticosteroid for inflammatory and pruritic skin condi…

• FDA approval · 2015-10-08
  FDA Approved: CICLOPIROX — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Ciclopirox from Sun Pharmaceutical Industries, Inc., under the ANDA framework. The approval indi…

• FDA approval · 2015-08-31
  FDA Approved: KETOCONAZOLE — Supplemental Application (THIRTY MADISON INC)

  FDA approved a supplemental application for Ketoconazole from Thirty Madison Inc under an existing ANDA, signaling an approved modification …

• FDA approval · 2014-07-18
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Desoximetasone from Sun Pharmaceutical Industries, updating or expanding its labeling.

• FDA approval · 2014-07-14
  FDA Approved: FLUOCINONIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's Original Application for fluocinonide, a topical corticosteroid, as a generic product. This marks regulatory cle…

• FDA approval · 2013-08-09
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a generic topical fluocinonide acetonide product under an original application from Padagis Israel Pharmaceuticals Ltd.

• 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 · 2009-03-18
  FDA Approved: KETOCONAZOLE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  FDA approved a supplemental ANDA for Ketoconazole, a generic antifungal product from E. Fougera & Co. (division of Fougera Pharmaceuticals).

• FDA approval · 2008-09-23
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original ANDA for topical betamethasone dipropionate, a generic corticosteroid, for inflammatory skin conditions…

• FDA approval · 2006-08-14
  FDA Approved: CLOBETASOL PROPIONATE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.)

  FDA approves a supplemental application for clobetasol propionate from E. Fougera & Co. (division of Fougera Pharmaceuticals Inc.), under th…