Dermatitis

• EMA approval · 2026-07-17
  EMA Authorised: Anzupgo (Delgocitinib) — LEO Pharma A/S

  Anzupgo (delgocitinib) has been authorised by the EMA for dermatitis/eczema with LEO Pharma A/S as the marketing authorization holder.

• FDA approval · 2025-12-16
  FDA Approved: BECLOMETHASONE DIPROPIONATE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's Beclomethasone Dipropionate as an original-application generic medication, a topical cortic…

• EMA approval · 2025-12-09
  EMA Authorised: Anzupgo (Delgocitinib) — LEO Pharma A/S

  The European Medicines Agency authorised Anzupgo (delgocitinib) by LEO Pharma A/S for dermatitis and eczema in the EU.

• FDA approval · 2025-11-10
  FDA Approved: CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a generic topical product containing ciprofloxacin hydrochloride and hydrocortisone under an original application for Cosette P…

• FDA approval · 2025-09-16
  FDA Approved: FLUOCINOLONE ACETONIDE OIL — Supplemental Application (RISING PHARMA HOLDINGS, INC.)

  FDA approved a supplemental application to add Fluocinolone Acetonide Oil as an approved topical formulation of fluocinolone acetonide by Ri…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2025-07-18
  FDA Approved: FLUOCINOLONE ACETONIDE OIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Fluocinonide Acetonide Oil, a topical corticosteroid product from Rising Pharma Holdings, In…

• FDA approval · 2025-04-11
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Dr. Reddy's Laboratories Inc)

  The FDA approved Dr. Reddy's Laboratories' Triamcinolone Acetonide as an original application (generic) for topical use, adding a generic co…

• FDA approval · 2025-02-26
  FDA Approved: FLUOCINONIDE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved fluocinonide from Quagen Pharmaceuticals LLC under an Original Application (ANDA 216389). This is a generic topical corticoster…

• FDA approval · 2024-11-25
  FDA Approved: HYDROCORTISONE — Original Application (Eywa Pharma Inc)

  FDA approved HYDROCORTISONE from Eywa Pharma Inc under an Original Application (ANDA 217160). This entry documents the approval of a generic…

• FDA approval · 2024-08-22
  FDA Approved: BETAMETHASONE VALERATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved an original ANDA for Betamethasone Valerate topical (Alembic Pharmaceuticals), a generic corticosteroid product for inflammator…

• FDA approval · 2024-05-29
  FDA Approved: HALCINONIDE TOPICAL SOLUTION — Original Application (INA Pharmaceutics Inc)

  FDA approved the Original Application for halcinonide topical solution from INA Pharmaceutics Inc, a generic version.

• FDA approval · 2024-04-30
  FDA Approved: HYDROCORTISONE BUTYRATE — Supplemental Application (The J. Molner Company LLC)

  FDA approves a supplemental application for hydrocortisone butyrate (ANDA 209556) by The J. Molner Company LLC. The approval updates the pro…

• FDA approval · 2024-04-10
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Aurobindo Pharma Limited)

  FDA approved Betamethasone dipropionate topical from Aurobindo Pharma Limited under an original ANDA for inflammatory and pruritic corticost…

• FDA approval · 2024-01-05
  FDA Approved: DEXAMETHASONE INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for DEXAMETHASONE INTENSOL from Hikma Pharmaceuticals USA, Inc., a dexamethasone 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 · 2023-08-23
  FDA Approved: DESOXIMETASONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for desoximetasone from Padagis Israel Pharmaceuticals Ltd, finalizing an update to the approved AND…

• FDA approval · 2023-07-17
  FDA Approved: HYDROCORTISONE — Original Application (Aurobindo Pharma Limited)

  FDA approved an original ANDA for hydrocortisone by Aurobindo Pharma Limited, marking the first approval of this generic product.

• FDA approval · 2023-04-18
  FDA Approved: BETAMETHASONE VALERATE — Original Application (Xiromed, LLC.)

  FDA approved Xiromed, LLC's Betamethasone Valerate Foam as an original ANDA, establishing a generic version of betamethasone valerate foam f…

• FDA approval · 2022-05-31
  FDA Approved: FLUOCINOLONE ACETONIDE OIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Fluocinonide Acetonide Oil from Rising Pharma Holdings, Inc., a topical corticosteroid produ…

• FDA approval · 2022-02-18
  FDA Approved: BETAMETHASONE DIPROPIONATE USP, 0.05% — Original Application (TruPharma LLC)

  FDA approved the Original Application for Betamethasone Dipropionate USP, 0.05% (topical corticosteroid) submitted by TruPharma LLC. It is a…

• FDA approval · 2022-02-17
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Quagen Pharmaceuticals LLC)

  FDA approved the original application for a generic clobetasol propionate topical product by Quagen Pharmaceuticals LLC.

• FDA approval · 2021-11-04
  FDA Approved: HYDROCORTISONE VALERATE CREAM — Original Application (Encube Ethicals, Inc.)

  FDA approved Hydrocortisone Valerate Cream by Encube Ethicals as an Original Application; a generic topical corticosteroid indicated for inf…

• 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 · 2021-04-02
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Quagen Pharmaceuticals LLC)

  FDA approved the Original Application for fluocinonide acetonide topical product. The generic is manufactured by Quagen Pharmaceuticals LLC.

• FDA approval · 2021-03-31
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic's generic Nystatin and Triamcinolone Acetonide for topical treatment of candidal skin infections and inflammatory derma…