Atopic Dermatitis

• FDA approval · 2015-02-18
  FDA Approved: MOMETASONE FUROATE — Supplemental Application (Encube Ethicals, Inc.)

  FDA approved a supplemental application for mometasone furoate from Encube Ethicals, Inc., granting approval of a supplemental ANDA for this…

• FDA approval · 2015-01-22
  FDA Approved: HYDROCORTISONE — Supplemental Application (Allegis Holdings LLC)

  FDA approved a supplemental application for HYDROCORTISONE lotion from Allegis Holdings LLC.

• FDA approval · 2015-01-20
  FDA Approved: BETAMETHASONE VALERATE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Betamethasone valerate from E. Fougera & Co., a division of Fougera Pharmaceuticals, LLC. Th…

• FDA approval · 2014-10-30
  FDA Approved: HYDROCORTISONE BUTYRATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for hydrocortisone butyrate from Oceanside Pharmaceuticals, expanding its regulatory status under ND…

• FDA approval · 2014-09-09
  FDA Approved: TACROLIMUS — Original Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  FDA approved a generic tacrolimus topical product under an original application; it is indicated for the treatment of atopic dermatitis.

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• 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 · 2014-07-14
  FDA Approved: FLUOCINONIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved an original application for fluocinonide from Sun Pharmaceutical Industries, a topical corticosteroid. The product is indicated…

• FDA approval · 2014-06-19
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Desoximetasone from Sun Pharmaceutical Industries, indicating approval of a supplemental for…

• FDA approval · 2014-06-04
  FDA Approved: PIMECROLIMUS — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Pimecrolimus from Oceanside Pharmaceuticals.

• FDA approval · 2014-06-03
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for hydroxyzine hydrochloride (HYDROXYZINE HYDROCHLORIDE) from Chartwell RX, LLC.

• FDA approval · 2014-05-15
  FDA Approved: TRIDESILON CREAM — Supplemental Application (Encore Dermatology Inc)

  FDA approved a supplemental application for TRIDESILON CREAM (desonide 0.05%), indicating a regulatory action related to this dermatology pr…

• FDA approval · 2014-05-12
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA has approved a supplemental application for Desoximetasone from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2014-04-17
  FDA Approved: ALCLOMETASONE DIPROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for alclometasone dipropionate by Glenmark Pharmaceuticals, approving changes to the product labelin…

• FDA approval · 2014-01-16
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for cyclosporine from Apotex Corp, authorizing changes under the generic product's regulatory fi…

• FDA approval · 2013-09-20
  FDA Approved: DESOXIMETASONE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's desoximetasone for topical use under an Original Application (ANDA), expanding available generic corticosteroid opti…

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

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

• 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 · 2013-07-23
  FDA Approved: CORDRAN — Supplemental Application (INA Pharmaceutics, Inc)

  FDA approved a supplemental application for Cordran (Flurandrenolide) submitted by INA Pharmaceutics, Inc. The update pertains to changes to…

• FDA approval · 2013-04-11
  FDA Approved: DESOXIMETASONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's desoximetasone topical product under an Original Application for the treatment of inflammatory and pruriti…

• FDA approval · 2013-03-20
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for desoximetasone from Sun Pharmaceutical Industries, Inc., resulting in an updated approval for th…

• FDA approval · 2012-11-26
  FDA Approved: BETAMETHASONE VALERATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a generic topical betamethasone valerate product from Padagis Israel Pharmaceuticals Ltd (Original Application).

• FDA approval · 2012-08-17
  FDA Approved: CLOBEX — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approved a supplemental application for CLOBEX (clobetasol propionate) submitted by Galderma Laboratories to update its labeling.

• FDA approval · 2012-08-09
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original application for clobetasol propionate topical product (a generic) from Padagis Israel Pharmaceuticals Ltd under AN…

• FDA approval · 2012-06-28
  FDA Approved: MICORT HC CREAM — Supplemental Application (Legacy Pharma USA Inc.)

  FDA approved a supplemental application for MICORT HC CREAM (hydrocortisone acetate cream) from Legacy Pharma USA Inc., representing an appr…