Allergic Rhinitis

• 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 · 2023-05-25
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer HealthCare LLC)

  The FDA approved a supplemental application for Claritin RediTabs (loratadine) to introduce a new dosage form for Bayer HealthCare LLC.

• FDA approval · 2023-05-24
  FDA Approved: RUGBY MOMETASONE FUROATE NASAL — Supplemental Application (Rugby Laboratories)

  FDA approved a supplemental application for Rugby Mometasone Furoate Nasal spray from Rugby Laboratories (NDA 215712). The approval pertaine…

• 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 · 2023-05-08
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for the cough/cold combination of brompheniramine maleate, pseudoephedrine hydrochloride, and dextro…

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• 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 · 2023-04-19
  FDA Approved: CETIRIZINE HYDROCHLORIDE ORAL SOLUTION — Supplemental Application (APOZEAL PHARMACEUTICALS INC)

  FDA approved a supplemental application for cetirizine hydrochloride oral solution by Apozeal Pharmaceuticals, updating the approved labelin…

• FDA approval · 2023-04-13
  FDA Approved: ALLERGY RELIEF — Supplemental Application (WALGREENS)

  FDA approves Walgreens' supplemental application for an allergy-relief product containing cetirizine hydrochloride (Allergy Relief).

• FDA approval · 2023-04-12
  FDA Approved: BUDESONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original application for Budesonide from Padagis Israel Pharmaceuticals Ltd, granting a generic version of budesonide. The …

• FDA approval · 2023-03-24
  FDA Approved: LORATADINE — Original Application (Aurohealth LLC)

  The FDA approved Aurohealth LLC's original application for loratadine, a generic antihistamine. It covers indications for allergic rhinitis …

• FDA approval · 2023-03-08
  FDA Approved: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE — Original Application (Aurohealth LLC)

  FDA approved Aurohealth LLC's cetirizine hydrochloride and pseudoephedrine hydrochloride as an original ANDA, enabling a generic combination…

• FDA approval · 2023-02-28
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a generic version of phenylephrine hydrochloride through an Original Application (ANDA 209968) by Heritage Pharmaceuticals (d/b…

• FDA approval · 2023-01-20
  FDA Approved: XHANCE — Supplemental Application (OptiNose US, Inc.)

  FDA approves a supplemental New Drug Application for XHANCE (fluticasone propionate) by OptiNose US, Inc.

• FDA approval · 2022-12-27
  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 Claritin (loratadine) from Bayer HealthCare…

• FDA approval · 2022-12-20
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Children's Allegra Allergy (fexofenadine hydrochloride) to support labeling for pediatric use, e…

• 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…

• FDA approval · 2022-11-02
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic promethazine hydrochloride under an original ANDA. The approval authorizes marketing of the gen…

• FDA approval · 2022-11-01
  FDA Approved: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex's azelastine hydrochloride and fluticasone propionate nasal spray, updating/expanding the…

• FDA approval · 2022-09-30
  FDA Approved: RYALTRIS — Supplemental Application (HIKMA SPECIALTY USA INC.)

  The FDA approved a supplemental application for RYALTRIS, a combination nasal spray of olopatadine hydrochloride and mometasone furoate, sub…

• FDA approval · 2022-09-29
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (NorthStar RxLLC)

  FDA approved phenylephrine hydrochloride under an original application for temporary relief of nasal congestion due to the common cold, hay …

• FDA approval · 2022-09-19
  FDA Tentative Approval: RUGBY MOMETASONE FUROATE NASAL — Supplemental Application (Rugby Laboratories)

  The FDA issued tentative approval for Rugby Mometasone Furoate Nasal from Rugby Laboratories under a supplemental application, indicating th…

• FDA approval · 2022-08-22
  FDA Approved: GUAIFENESIN AND PSEUDOEPHEDRINE HCL — Original Application (Granules India Ltd)

  FDA approved Granules India Ltd's guaifenesin and pseudoephedrine HCl as an Original Application (ANDA) for a generic combination product.

• FDA approval · 2022-07-15
  FDA Approved: RUGBY MOMETASONE FUROATE NASAL — Supplemental Application (Rugby Laboratories)

  FDA granted a supplemental approval for Rugby Mometasone Furoate Nasal (mometasone furoate) from Rugby Laboratories.

• FDA approval · 2022-07-08
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Publix Super Markets Inc)

  FDA approved a supplemental application for Allergy Relief containing fexofenadine hydrochloride, submitted by Publix Super Markets Inc.

• FDA approval · 2022-06-16
  FDA Approved: FLUNISOLIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original application for flunisolide from Ingenus Pharmaceuticals, confirming the generic product's approval for its indica…