Allergic Rhinitis

• FDA approval · 2024-05-17
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., authorizing its generic montelukast pr…

• FDA approval · 2024-05-14
  FDA Approved: ALLERGY RELIEF-D — Original Application (HEB)

  FDA approves ALLERGY RELIEF-D, a combination product of loratadine and pseudoephedrine sulfate, under an original application by HEB, for re…

• FDA approval · 2024-05-10
  FDA Approved: 365 WHOLE FOODS MARKET FLUTICASONE PROPIONATE — Original Application (Whole Foods Market, Inc.)

  The FDA approved the original application for 365 Whole Foods Market Fluticasone Propionate, a generic nasal spray containing fluticasone pr…

• FDA approval · 2024-03-20
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved a generic diphenhydramine hydrochloride product through an Original Application (ANDA 218448) by Sagent Pharmaceuticals.

• FDA approval · 2024-03-15
  FDA Approved: XHANCE — Supplemental Application (OptiNose US, Inc.)

  FDA approved a supplemental application for XHANCE (fluticasone propionate) submitted by OptiNose US, Inc. The action updates the product la…

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• FDA approval · 2024-01-04
  FDA Approved: ALLERGY RELIEF — Supplemental Application (WALMART INC. (see also Equate))

  FDA approved a supplemental application for ALLERGY RELIEF containing fexofenadine HCl, manufactured by Walmart Inc.

• FDA approval · 2023-12-15
  FDA Approved: TUXARIN — Supplemental Application (Mainpointe Pharmaceuticals)

  FDA approved a supplemental application for TUXARIN (codeine phosphate and chlorpheniramine maleate) submitted by Mainpointe Pharmaceuticals…

• FDA approval · 2023-12-05
  FDA Approved: PREDNISONE TABLETS, USP, 5 MG — Supplemental Application (Granulation Technology, Inc.)

  FDA granted a supplemental approval for Prednisone Tablets, USP, 5 mg to authorize a granulation technology manufacturing change by Granulat…

• FDA approval · 2023-11-27
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Montelukast Sodium from Dr. Reddy's Laboratories Limited under an ANDA, enabling a supplemental …

• FDA approval · 2023-11-20
  FDA Approved: ASTEPRO ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for AStepro Allergy (azelastine HCl) from Bayer HealthCare LLC.

• FDA approval · 2023-11-15
  FDA Approved: FLONASE SENSIMIST ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  The FDA granted a supplemental approval for Flonase Sensimist Allergy Relief (fluticasone furoate) manufactured by Haleon US Holdings LLC.

• FDA approval · 2023-11-15
  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) from Haleon US Holdings LLC.

• FDA approval · 2023-11-09
  FDA Approved: CLARITIN-D 12 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin-D 12 Hour (loratadine and pseudoephedrine sulfate) from Bayer HealthCare LLC. This acti…

• FDA approval · 2023-11-09
  FDA Approved: CLARITIN-D 24 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved Bayer’s supplemental application for Claritin-D 24 Hour, adding a 24-hour loratadine and pseudoephedrine sulfate formulation. T…

• FDA approval · 2023-10-13
  FDA Approved: LORATADINE — Supplemental Application (Wal-Mart Stores, Inc)

  The FDA approved a supplemental application for loratadine submitted by Wal-Mart Stores, Inc. for an existing loratadine product.

• FDA approval · 2023-09-21
  FDA Approved: MONTELUKAST — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Montelukast from XLCare Pharmaceuticals Inc., authorizing a supplemental action related to a…

• FDA approval · 2023-08-08
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Fluticasone Propionate by Padagis Israel Pharmaceuticals Ltd, indicating an approved update to a…

• FDA approval · 2023-07-31
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Montelukast Sodium from Macleods Pharmaceuticals Limited, authorizing continued marketing of thi…

• FDA approval · 2023-07-28
  FDA Approved: LORATADINE — Original Application (Camber Consumer Care Inc)

  The FDA approved Camber Consumer Care Inc's loratadine product via an Original Application (ANDA211718), providing a generic loratadine opti…

• FDA approval · 2023-06-28
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental ANDA for Montelukast Sodium by Unichem Pharmaceuticals (USA), Inc., granting approval for its generic product. M…

• FDA approval · 2023-06-12
  FDA Approved: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for the azelastine hydrochloride and fluticasone propionate nasal spray from Padagis Israel Pharmace…

• FDA approval · 2023-06-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Montelukast Sodium submitted by Camber Pharmaceuticals, Inc., under the approved ANDA.

• FDA approval · 2023-06-07
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Montelukast submitted by BluePoint Laboratories.

• FDA approval · 2023-06-07
  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…

• EMA approval · 2023-06-01
  EMA Authorised: Desloratadine Actavis (desloratadine) — Actavis Group PTC ehf

  The EMA has authorised Desloratadine Actavis (desloratadine) for allergic rhinitis and urticaria indications in the European Union.