Idiopathic Urticaria

• FDA label_change · 2024-07-11
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application to add Claritin Chewable Grape and Bubblegum (loratadine) as a chewable formulation from Bayer H…

• FDA label_change · 2022-11-04
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Publix Super Markets Inc)

  FDA approved a supplemental application for Allergy Relief (fexofenadine hydrochloride) from Publix Super Markets Inc under ANDA 212971.

• FDA label_change · 2022-10-28
  FDA Approved: CHILDRENS XYZAL ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application to modify the labeling of CHILDRENS XYZAL ALLERGY (levocetirizine dihydrochloride) for pediatric use…

• FDA label_change · 2019-10-31
  FDA Approved: CAREONE ALLERGY RELIEF — Supplemental Application (American Sales Company)

  FDA approved a supplemental application for CAREONE ALLERGY RELIEF containing fexofenadine HCl, submitted by American Sales Company.

• FDA label_change · 2019-01-11
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) from Chattem, Inc., resulting in changes to the produ…

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• FDA label_change · 2016-08-09
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental application for Claritin (loratadine) submitted by Bayer HealthCare LLC, indicating a labeling change for the ma…

• FDA label_change · 2016-06-23
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) submitted by Chattem, Inc., likely resulting in labeling …

• FDA label_change · 2013-11-29
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for levocetirizine dihydrochloride submitted by Glenmark Pharmaceuticals Inc., USA. This action …

• FDA label_change · 2010-03-10
  FDA Approved: COUNTERACT ALLERGY — Supplemental Application (Melaleuca, Inc.)

  The FDA approved Melaleuca, Inc.'s supplemental application for COUNTERACT ALLERGY (loratadine), resulting in a labeling update for the prod…

• FDA label_change · 2009-03-20
  FDA Approved: LORATADINE ANTIHISTAMINE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approves a supplemental labeling application for loratadine antihistamine from Padagis Israel Pharmaceuticals Ltd, resulting in updated …

• FDA label_change · 2006-12-14
  FDA Approved: CLARINEX — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for CLARINEX (desloratadine) from Organon LLC. The approval updates the product labeling.