Allergic Rhinitis

• FDA label_change · 2017-04-26
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental application for Claritin (loratadine) by Bayer HealthCare LLC to update the product labeling.

• FDA label_change · 2017-03-24
  FDA Approved: ADVIL ALLERGY SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application to update the labeling for ADVIL ALLERGY SINUS, a three-drug combination (chlorpheniramine maleate, …

• FDA label_change · 2016-09-22
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  FDA supplemental application for NASACORT ALLERGY 24HR (triamcinolone acetonide) to update the product labeling.

• FDA label_change · 2016-08-23
  FDA Approved: ZYRTEC ALLERGY — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC ALLERGY (cetirizine hydrochloride) submitted by Kenvue Brands LLC, indicating a modificat…

• 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…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA label_change · 2016-08-01
  FDA Approved: ZYRTEC ALLERGY — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC ALLERGY (cetirizine hydrochloride) submitted by Kenvue Brands LLC. The action concerns ch…

• 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 · 2015-09-30
  FDA Approved: CHILDRENS FLONASE ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Children's Flonase Allergy Relief (fluticasone propionate) from Haleon US Holdings LLC, upda…

• FDA label_change · 2015-09-24
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  FDA supplemental application to update the labeling for Allegra Hives 24HR (fexofenadine hydrochloride) submitted by Chattem, Inc.

• FDA label_change · 2015-06-08
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Allegra-D Allergy and Congestion (fexofenadine hydrochloride and pseudoephedrine hydrochlori…

• FDA label_change · 2014-09-19
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  FDA note of a supplemental application for Nasacort Allergy 24HR (triamcinolone acetonide) by Chattem, Inc., likely supporting labeling chan…

• FDA label_change · 2014-02-14
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  FDA has received a supplemental application for XYZAL (levocetirizine dihydrochloride) from Chattem, Inc.

• 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 · 2013-09-10
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

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

• FDA label_change · 2013-06-12
  FDA Approved: OMNARIS — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Omnaris (ciclesonide) submitted by Covis Pharma US, Inc., resulting in changes to the produc…

• FDA label_change · 2013-03-22
  FDA Approved: OMNARIS — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Omnaris (ciclesonide) from Covis Pharma US, Inc., resulting in changes to the product’s labe…

• FDA label_change · 2013-03-21
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) from Organon LLC, resulting in a labeling change for the product.

• FDA label_change · 2011-12-01
  FDA Approved: ZYRTEC ALLERGY — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC ALLERGY (cetirizine hydrochloride) filed by Kenvue Brands LLC, updating the product label…

• FDA label_change · 2011-07-07
  FDA Approved: CHILDRENS ALLERGY — Supplemental Application (Publix Super Markets Inc)

  FDA approved a supplemental application for a cetirizine hydrochloride product labeled as Children's Allergy by Publix Super Markets, updati…

• FDA label_change · 2010-04-26
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair to update labeling; Organon LLC submitted the request.

• FDA label_change · 2010-04-06
  FDA Approved: CETIRIZINE HCL — Supplemental Application (AMERISOURCE BERGEN)

  FDA approved a supplemental application for cetirizine HCl submitted by Amerisource Bergen, indicating a labeling change to the product.

• 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 · 2010-03-03
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application to expand Claritin Chewable by adding grape and bubblegum flavored loratadine chewables, under B…

• 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 · 2008-10-21
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a labeling supplement for Claritin Chewable Grape and Bubblegum (loratadine) by Bayer HealthCare LLC.