Allergic Rhinitis

• FDA approval · 2020-06-01
  FDA Approved: KETOTIFEN FUMARATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for ketotifen fumarate as a generic antihistamine product. This mark…

• FDA approval · 2020-05-08
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for azelastine hydrochloride from Aurobindo Pharma Limited.

• FDA approval · 2020-04-29
  FDA Approved: CURIST ALLERGY RELIEF — Original Application (Little Pharma, Inc.)

  FDA approved Little Pharma, Inc.'s CURIST ALLERGY RELIEF as the original ANDA for levocetirizine dihydrochloride 5 mg, a generic tablet for …

• FDA approval · 2020-04-17
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved the original application for a generic combination cough/cold medicine containing brompheniramine maleate, pseudoephedrine hydr…

• FDA approval · 2020-03-17
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for Diphenhydramine hydrochloride from PAI Pharma, indicating an approved modification to an existin…

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• FDA approval · 2020-03-05
  FDA Approved: LORATADINE — Supplemental Application (Wal-Mart Stores, Inc)

  FDA approved a supplemental application for loratadine submitted by Wal-Mart Stores, Inc., updating an already approved product under ANDA21…

• FDA approval · 2020-03-03
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for Allergy Relief (loratadine) from Ohm Laboratories Inc.

• FDA approval · 2020-03-03
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for cetirizine hydrochloride from Padagis Israel Pharmaceuticals Ltd. It is a generic antihistamine …

• FDA approval · 2020-03-03
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for cetirizine hydrochloride by Bionpharma Inc., under ANDA078488, granting regulatory approval …

• FDA approval · 2020-02-18
  FDA Approved: MONTELUKAST SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for Montelukast Sodium, a generic montelukast product.

• FDA approval · 2019-12-31
  FDA Approved: GOOD SENSE LEVOCETIRIZINE — Supplemental Application (L. Perrigo Company)

  FDA approved a supplemental application for Good Sense Levocetirizine (levocetirizine dihydrochloride) from L. Perrigo Company.

• FDA approval · 2019-12-23
  FDA Approved: LORATADINE — Original Application (GRANULES USA, INC.)

  FDA approved Granules USA, Inc.'s loratadine Original Application, granting a generic loratadine tablet product.

• FDA approval · 2019-12-13
  FDA Approved: CETIRIZINE HCL — Supplemental Application (AMERISOURCE BERGEN)

  FDA approved a supplemental application for Cetirizine HCl submitted by AmerisourceBergen, updating the NDA to reflect the approved suppleme…

• FDA approval · 2019-12-06
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for montelukast sodium (generic montelukast).

• FDA approval · 2019-11-25
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Fluticasone Propionate from Hikma Pharmaceuticals USA Inc., under the ANDA program.

• FDA approval · 2019-11-14
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Glenmark's generic fluticasone propionate nasal spray.

• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Montelukast submitted by BluePoint Laboratories. The action pertains to an additional indication…

• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, updating regulatory status for the product.

• FDA approval · 2019-11-07
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

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

• FDA approval · 2019-11-07
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's supplemental application for montelukast sodium under ANDA202717, resulting in an updated approved product.…

• FDA approval · 2019-11-05
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., enabling a generic product entry. This dec…

• FDA approval · 2019-10-29
  FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for Budesonide by Rite Aid Corporation, expanding or modifying the approval of this generic product.

• FDA approval · 2019-10-25
  FDA Approved: ALLERGY RELIEF 24HR — Supplemental Application (VELOCITY PHARMA LLC)

  FDA approved a supplemental application for ALLERGY RELIEF 24HR (levocetirizine dihydrochloride) by Velocity Pharma LLC.

• FDA approval · 2019-10-22
  FDA Approved: DESLORATADINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approves a supplemental application for desloratadine submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2019-10-22
  FDA Approved: DESLORATADINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for desloratadine, a generic antihistamine used to treat allergy symptoms.