Allergic Rhinitis

• FDA label_change · 2025-09-15
  FDA Approved: FLONASE SENSIMIST ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Flonase Sensimist Allergy Relief (fluticasone furoate nasal spray), under Haleon US Holdings…

• FDA label_change · 2025-07-28
  FDA Approved: QUZYTTIR — Supplemental Application (TerSera Therapeutics LLC)

  FDA approves a supplemental application for QUZYTTIR (cetirizine hydrochloride) filed by TerSera Therapeutics, updating the product labeling…

• FDA label_change · 2025-07-22
  FDA Approved: CHILDRENS XYZAL ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental labeling application for Children's XYZAL Allergy (levocetirizine dihydrochloride) by Chattem, Inc.

• FDA label_change · 2025-07-11
  FDA 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…

• FDA label_change · 2025-07-11
  FDA 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 · 2025-01-10
  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) by Haleon US Holdings LLC.

• FDA label_change · 2025-01-10
  FDA Approved: FLONASE SENSIMIST ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Flonase Sensimist Allergy Relief (fluticasone furoate) by Haleon US Holdings LLC to update t…

• 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 · 2023-12-27
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Promethazine hydrochloride from Hikma Pharmaceuticals USA, authorizing changes to the product la…

• FDA label_change · 2023-08-29
  FDA Approved: RYALTRIS — Supplemental Application (HIKMA SPECIALTY USA INC.)

  FDA approved a supplemental application for RYALTRIS (olopatadine hydrochloride and mometasone furoate) submitted by Hikma Specialty USA Inc…

• FDA label_change · 2023-05-10
  FDA Approved: METHYLPREDNISOLONE ACETATE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for methylprednisolone acetate by Sandoz Inc.

• 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 · 2020-11-30
  FDA Approved: ZYRTEC — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC (cetirizine hydrochloride) to update the product labeling.

• FDA label_change · 2020-03-03
  FDA Approved: CHILDREN ALLERGY — Supplemental Application (Walgreens)

  FDA approved a supplemental application for a pediatric allergy indication using fexofenadine hydrochloride (Children's Allergy), expanding …

• FDA label_change · 2020-03-03
  FDA 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.

• 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 · 2019-06-17
  FDA 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.

• FDA label_change · 2019-02-28
  FDA 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.…

• FDA label_change · 2019-02-06
  FDA 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…

• 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…

• FDA label_change · 2018-12-21
  FDA 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.

• FDA label_change · 2018-10-11
  FDA 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…

• FDA label_change · 2018-06-27
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for levocetirizine dihydrochloride (Glenmark Pharmaceuticals Inc., USA) under the ANDA process, lead…

• FDA label_change · 2018-06-04
  FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Liqui-Gels (loratadine) from Bayer HealthCare LLC.