Urticaria
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2025-07-28FDA Approved: QUZYTTIR — Supplemental Application (TerSera Therapeutics LLC)
FDA approves a supplemental application for QUZYTTIR (cetirizine hydrochloride) filed by TerSera Therapeutics, updating the product labeling…
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FDA label_change · 2025-07-22FDA Approved: CHILDRENS XYZAL ALLERGY — Supplemental Application (Chattem, Inc.)
FDA approved a supplemental labeling application for Children's XYZAL Allergy (levocetirizine dihydrochloride) by Chattem, Inc.
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FDA label_change · 2025-07-11FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical's supplemental application for cetirizine hydrochloride, resulting in changes to the product labeling. C…
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FDA label_change · 2025-07-11FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for cetirizine hydrochloride, indicating a labeling or formulation-related update for the drug.
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FDA label_change · 2025-04-24FDA Approved: ZYRTEC HIVES — Supplemental Application (Kenvue Brands LLC)
FDA supplemental application for ZYRTEC HIVES to support labeling for cetirizine hydrochloride in the treatment of urticaria (hives).
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FDA label_change · 2020-11-30FDA Approved: ZYRTEC — Supplemental Application (Kenvue Brands LLC)
FDA approved a supplemental application for ZYRTEC (cetirizine hydrochloride) to update the product labeling.
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FDA label_change · 2020-03-03FDA Approved: CHILDREN ALLERGY — Supplemental Application (Walgreens)
FDA approved a supplemental application for a pediatric allergy indication using fexofenadine hydrochloride (Children's Allergy), expanding …
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FDA label_change · 2020-03-03FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a supplemental application for cetirizine hydrochloride from Sun Pharmaceutical to update labeling under an ANDA.
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FDA label_change · 2019-08-07FDA Approved: ZYRTEC HIVES — Supplemental Application (Kenvue Brands LLC)
The FDA approved a supplemental indication to expand ZYRTEC HIVES (cetirizine hydrochloride) for the treatment of urticaria (hives). The pro…
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FDA label_change · 2019-06-17FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Claritin Chewable Grape and Bubblegum (loratadine) from Bayer HealthCare LLC.
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FDA label_change · 2019-02-28FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Claritin Allergy (loratadine) by Bayer HealthCare LLC, indicating a labeling change or addition.…
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FDA label_change · 2019-02-06FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)
FDA approved a supplemental application for Claritin (loratadine) submitted by Bayer HealthCare LLC. The action involves updates to the prod…
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FDA label_change · 2018-12-21FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Claritin Liqui-Gels (loratadine) by Bayer HealthCare LLC, indicating a labeling-related update.
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FDA label_change · 2018-10-11FDA Approved: CHILDRENS ZYRTEC — Supplemental Application (Kenvue Brands LLC)
FDA approved a supplemental labeling action for Children's Zyrtec (cetirizine hydrochloride) by Kenvue Brands LLC. The action updates the pr…
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FDA label_change · 2018-06-04FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Claritin Liqui-Gels (loratadine) from Bayer HealthCare LLC.
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FDA label_change · 2017-04-26FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)
FDA approved a supplemental application for Claritin (loratadine) by Bayer HealthCare LLC to update the product labeling.
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FDA label_change · 2016-08-23FDA 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…
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FDA label_change · 2016-08-01FDA 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…
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FDA label_change · 2016-05-10FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)
FDA approved a supplemental application for Allegra Hives 24HR (fexofenadine hydrochloride) from Chattem, Inc.
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FDA label_change · 2015-09-24FDA 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.
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FDA label_change · 2013-09-10FDA 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 …
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FDA label_change · 2012-03-13FDA Approved: ZYRTEC HIVES — Supplemental Application (Kenvue Brands LLC)
FDA approved a supplemental application for ZYRTEC HIVES to expand cetirizine hydrochloride labeling to include treatment of hives (urticari…
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FDA label_change · 2011-07-07FDA 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…
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FDA label_change · 2010-04-06FDA 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.
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FDA label_change · 2010-03-03FDA 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…