Dermatitis

• FDA approval · 2018-12-14
  FDA Approved: HYDROCORTISONE VALERATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's hydrocortisone valerate as a generic topical corticosteroid under an original ANDA (ANDA211750).

• FDA approval · 2018-11-29
  FDA Approved: FLUOCINONIDE — Original Application (Encube Ethicals, Inc.)

  The FDA approved Encube Ethicals, Inc.'s fluocinonide topical solution 0.05% as a generic topical corticosteroid for inflammatory and prurit…

• 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 · 2018-10-16
  FDA Approved: FLUOCINONIDE — Original Application (Encube Ethicals, Inc.)

  FDA approved Fluocinonide under Encube Ethicals, Inc.'s Original Application (ANDA 211410), establishing regulatory approval for this topica…

• FDA approval · 2018-10-12
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved Cosette Pharmaceuticals' original application for a generic Betamethasone Dipropionate topical product.

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• FDA approval · 2018-10-04
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved CLOBETASOL PROPIONATE as an original-application generic topical product. The approval holder is Taro Pharmaceuticals U.S.A., I…

• FDA approval · 2018-08-21
  FDA Approved: FLUOCINONIDE CREAM — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a generic fluocinonide cream from Amneal Pharmaceuticals NY LLC (ANDA 210554).

• FDA approval · 2018-07-17
  FDA Approved: FLUOCINONIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved the fluocinonide topical product from Zydus Lifesciences Limited via an Original Application, marking the first generic entry f…

• FDA approval · 2018-06-27
  FDA Approved: METHYLPREDNISOLONE ACETATE — Original Application (Sagent Pharmaceuticals)

  The FDA approved the original application for methylprednisolone acetate from Sagent Pharmaceuticals, enabling a generic topical corticoster…

• FDA approval · 2018-04-23
  FDA Approved: FLUOCINONIDE — Original Application (NorthStar RxLLC)

  FDA approved Fluocinonide through an Original Application (generic) submitted by NorthStar RxLLC.

• FDA approval · 2018-03-28
  FDA Approved: DIPROLENE — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Diprolene (betamethasone dipropionate) from Organon LLC.

• FDA approval · 2018-03-16
  FDA Approved: DESOXIMETASONE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' desoximetasone topical product under an original application, enabling a generic version of this topical…

• FDA approval · 2018-01-30
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic clobetasol propionate topical as an Original Application (ANDA). It is indicated for inflammator…

• 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 · 2017-10-27
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for a generic clobetasol propionate topical product from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2017-09-19
  FDA Approved: DESOXIMETASONE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved Desoximetasone from Viona Pharmaceuticals Inc via an Original Application (ANDA205206).

• 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 · 2017-07-21
  FDA Approved: FLUOCINONIDE — Original Application (Novel Laboratories, Inc.)

  FDA approval for fluocinonide from Novel Laboratories, Inc. as an Original Application (ANDA), representing first-time approval of this gene…

• FDA approval · 2017-07-17
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved Padagis Israel Pharmaceuticals Ltd's generic fluocinonide acetonide as an original application (ANDA 202849) for topical tr…

• FDA approval · 2017-05-26
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for betamethasone dipropionate from Sun Pharmaceutical Industries, Inc., authorizing an update to th…

• FDA approval · 2017-05-24
  FDA Approved: BETAMETHASONE VALERATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries, Inc.'s original generic application for Betamethasone valerate. This approval makes the generic …

• 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 · 2017-02-16
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original ANDA for clobetasol propionate topical corticosteroid from Zydus Lifesciences Limited.

• FDA approval · 2017-01-12
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approves Cosette Pharmaceuticals' original ANDA for Triamcinolone Acetonide topical (generic), clearing a new generic product on the mar…

• FDA approval · 2017-01-11
  FDA Approved: DESOXIMETASONE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' desoximetasone topical generic under an Original Application (ANDA 208163).