Idiopathic Urticaria

• FDA approval · 2018-01-19
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved Dr. Reddy's Laboratories' original ANDA for levocetirizine dihydrochloride, a generic antihistamine indicated for relief of…

• FDA approval · 2017-12-27
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Vensun Pharmaceuticals, Inc.)

  FDA approved a supplemental application for levocetirizine dihydrochloride (Vensun Pharmaceuticals, Inc.) under an ANDA. This action maintai…

• FDA approval · 2017-09-18
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental ANDA for levocetirizine dihydrochloride from Teva Pharmaceuticals USA, Inc., expanding the availability of a gen…

• FDA approval · 2017-09-18
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Levocetirizine dihydrochloride by Macleods Pharmaceuticals Limited under ANDA205564.

• FDA approval · 2017-09-15
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Supplemental Application (7-eleven)

  FDA approved a supplemental application for fexofenadine hydrochloride (ANDA 202039) submitted by 7-eleven.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2017-07-10
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) submitted by Chattem, Inc.

• FDA approval · 2017-05-15
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Chartwell RX, LLC)

  FDA approved the original application for levocetirizine dihydrochloride (generic) from Chartwell RX, LLC.

• FDA approval · 2017-02-09
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) from Chattem, Inc., approving changes to the product's la…

• FDA approval · 2017-01-31
  FDA Approved: XYZAL ALLERGY 24HR — Original Application (Chattem, Inc.)

  FDA Approved: XYZAL ALLERGY 24HR (levocetirizine dihydrochloride) by Chattem, Inc. under an Original Application. The product is indicated f…

• FDA approval · 2016-11-08
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for cetirizine hydrochloride from PAI Holdings, LLC dba PAI Pharma. This action approves a supplemen…

• FDA approval · 2016-09-23
  FDA Approved: LORATADINE — Original Application (MARKSANS PHARMA LIMITED)

  FDA approved loratadine via an Original Application (ANDA) for Marksans Pharma Limited, expanding access to a generic antihistamine.

• FDA approval · 2016-08-19
  FDA Approved: FEXOFENADINE HCL — Original Application (Strategic Sourcing Services)

  FDA approves the original application for fexofenadine hydrochloride, a generic antihistamine, submitted by Strategic Sourcing Services.

• FDA approval · 2016-06-16
  FDA Approved: CLARINEX — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for CLARINEX (desloratadine) submitted by Organon LLC. The action confirms regulatory approval relat…

• FDA approval · 2016-05-26
  FDA Approved: DESLORATADINE ORAL SOLUTION — Original Application (INA Pharmaceutics, Inc.)

  INA Pharmaceutics' Desloratadine oral solution received FDA approval as a generic version of desloratadine for allergic rhinitis and chronic…

• FDA approval · 2016-01-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for levocetirizine dihydrochloride from Macleods Pharmaceuticals Limited as a generic antihistamine.

• FDA approval · 2015-11-25
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for Glenmark Pharmaceuticals' generic levocetirizine dihydrochloride.

• FDA approval · 2015-11-24
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Camber Pharmaceuticals, confirming its status as a generic a…

• FDA approval · 2015-10-01
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals Inc)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Marlex Pharmaceuticals Inc, indicating an approved regulator…

• FDA approval · 2015-09-24
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Claritin Chewable Grape and Bubblegum (loratadine) from Bayer HealthCare LLC, expanding the …

• FDA approval · 2015-09-16
  FDA Approved: FEXOFENADINE HCL — Original Application (AKRON PHARMA INC)

  FDA approved Akron Pharma Inc's original ANDA for fexofenadine hydrochloride (Fexofenadine HCl), a generic antihistamine for allergic rhinit…

• FDA approval · 2015-07-31
  FDA Approved: LORATADINE — Original Application (WALGREEN COMPANY)

  FDA approves Walgreens' original submission for Loratadine (ANDA 201865), granting generic approval for loratadine. Loratadine is an antihis…

• FDA approval · 2015-02-25
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Supplemental Application (AMERISOURCE BERGEN)

  FDA approved a supplemental application for fexofenadine hydrochloride submitted by Amerisource Bergen, updating the regulatory status of th…

• FDA approval · 2015-02-11
  FDA Approved: DESLORATADINE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for desloratadine filed by Bionpharma Inc.

• FDA approval · 2015-02-11
  FDA Approved: DESLORATADINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for desloratadine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2014-11-19
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Original Application (7-eleven)

  FDA approved a generic version of fexofenadine hydrochloride (ANDA 202039) for allergic rhinitis and chronic urticaria, with 7-eleven as the…