Idiopathic Urticaria

• FDA approval · 2026-01-07
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals Inc)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Marlex Pharmaceuticals Inc., updating the approved generic p…

• FDA approval · 2025-11-25
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (BAJAJ MEDICAL, LLC)

  FDA approved a supplemental application for cetirizine hydrochloride from Bajaj Medical, LLC, authorizing continued marketing of the generic…

• FDA approval · 2025-07-17
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride submitted by Rising Pharma Holdings, Inc. The approval relates to chang…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for levocetirizine dihydrochloride (generic) submitted by Chartwell RX, LLC.

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals Inc)

  FDA approved a supplemental application for Levocetirizine dihydrochloride from Marlex Pharmaceuticals Inc, granting regulatory authorizatio…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Glenmark, indicating an approved modification to an existing…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Dr.Reddy's laboratories Ltd.)

  The FDA approved a supplemental application for levocetirizine dihydrochloride from Dr. Reddy's Laboratories, indicating an FDA regulatory a…

• FDA approval · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for cetirizine hydrochloride from Amneal Pharmaceuticals LLC, authorizing modifications to the produ…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Macleods Pharmaceuticals Limited.

• FDA approval · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE ORAL SOLUTION — Supplemental Application (APOZEAL PHARMACEUTICALS INC)

  FDA approved a supplemental application for cetirizine hydrochloride oral solution from Apozeal Pharmaceuticals Inc, expanding labeling for …

• FDA approval · 2025-07-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride, adding an oral solution dosage form for this generic product (Heritage…

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Vensun Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Levocetirizine dihydrochloride from Vensun Pharmaceuticals, Inc., updating the approved product …

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Padagis Israel Pharmaceuticals Ltd, indicating a regulatory …

• FDA approval · 2025-07-11
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application to market a generic levocetirizine dihydrochloride product. The product is…

• FDA approval · 2025-06-13
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals Inc)

  FDA approved a supplemental application for Levocetirizine Dihydrochloride from Marlex Pharmaceuticals Inc.

• FDA approval · 2025-06-10
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Chartwell RX, LLC.

• FDA approval · 2025-04-17
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to introduce Claritin Chewable Grape and Bubblegum (loratadine) by Bayer HealthCare LLC. This approv…

• FDA approval · 2025-04-03
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for levocetirizine dihydrochloride (Dr. Reddy's Laboratories Inc.), confirming the generic's labelin…

• FDA approval · 2024-11-21
  FDA Approved: LORATADINE 10 MG — Original Application (TIME CAP LABORATORIES, INC.)

  FDA approved Time Cap Laboratories, Inc.'s loratadine 10 mg tablets via an original ANDA, establishing a generic version of the antihistamin…

• FDA approval · 2024-07-11
  FDA Approved: XYZAL ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for XYZAL ALLERGY 24HR (levocetirizine dihydrochloride) filed by Chattem, Inc., related to a sup…

• FDA approval · 2023-05-31
  FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin LiQui-Gels (loratadine). The new liquid-filled gel capsule formulation expands the Clar…

• FDA approval · 2023-05-23
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Original Application (Aurohealth LLC)

  FDA approves Aurohealth LLC's generic fexofenadine hydrochloride (oral) under Orig AP; indicated for allergic rhinitis and chronic idiopathi…

• FDA approval · 2023-05-01
  FDA Approved: DESLORATADINE — Supplemental Application (Virtus Pharmaceuticals, LLC)

  FDA approved a supplemental application for desloratadine from Virtus Pharmaceuticals, LLC.

• FDA approval · 2023-03-17
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) submitted by Genentech, Inc., representing an additional regulatory action f…

• FDA approval · 2022-12-08
  FDA Approved: LORATADINE ODT — Supplemental Application (Aurohealth LLC)

  FDA approved a supplemental application for Loratadine ODT from Aurohealth LLC, updating the labeling for loratadine in an orally disintegra…