Allergic Rhinitis

• FDA approval · 2025-08-15
  FDA Approved: FLUTICASONE PROPIONATE — Original Application (Advagen Pharma Ltd.)

  FDA approved Advagen Pharma Ltd.'s original application for a generic Fluticasone Propionate nasal spray. The product is indicated for relie…

• FDA approval · 2025-08-01
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for cetirizine hydrochloride from Sandoz Inc, granting regulatory clearance for this generic ant…

• 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…

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

  FDA approved a supplemental application for cetirizine hydrochloride from Padagis Israel Pharmaceuticals Ltd, confirming approval under a su…

• 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 (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's levocetirizine dihydrochloride under an ANDA. The notice indicates an approved supplement…

• 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: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride from Rising Pharma Holdings, Inc.

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

  FDA approved Camber Pharmaceuticals' supplemental application for levocetirizine dihydrochloride, a generic antihistamine, under an ANDA.

• FDA approval · 2025-07-01
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for Montelukast Sodium from Ajanta Pharma USA Inc., under an ANDA.

• EMA approval · 2025-06-27
  EMA Authorised: Avamys (fluticasone furoate) — GlaxoSmithKline Trading Services Limited

  EMA has authorised Avamys (fluticasone furoate) nasal spray for allergic rhinitis, including seasonal and perennial forms.

• FDA approval · 2025-06-24
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for promethazine hydrochloride from Hikma Pharmaceuticals USA, confirming the approval of a generic …

• 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 · 2025-05-20
  FDA Approved: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical Industries' Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride, updat…

• FDA approval · 2025-05-14
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add a new chewable grape and bubblegum formulation of loratadine (Claritin) by Bayer HealthCare L…