Allergic Rhinitis

• FDA approval · 2010-05-28
  FDA Approved: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application from Dr. Reddy's Laboratories Limited for a fexofenadine HCl and pseudoephedrine HCl combination pro…

• FDA approval · 2010-05-27
  FDA Approved: BETR REMEDIES ALL DAY ALLERGY RELIEF — Supplemental Application (Live Betr LLC)

  The FDA approved a supplemental application for BETR REMEDIES ALL DAY ALLERGY RELIEF, a cetirizine hydrochloride product from Live Betr LLC.

• FDA approval · 2010-04-14
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Allegra-D Allergy and Congestion (fexofenadine hydrochloride and pseudoephedrine hydrochloride) …

• FDA approval · 2010-04-14
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Allegra-D Allergy and Congestion (fexofenadine hydrochloride and pseudoephedrine hydrochlori…

• FDA approval · 2010-02-19
  FDA Approved: DESLORATADINE — Original Application (Bionpharma Inc.)

  FDA approved the original ANDA for desloratadine from Bionpharma Inc., a generic antihistamine. The approval is for the treatment of allergi…

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• FDA approval · 2010-02-02
  FDA Approved: CHILDRENS ALLERGY RELIEF — Original Application (C.D.M.A., Inc.)

  FDA approved the original ANDA for CHILDRENS ALLERGY RELIEF containing cetirizine hydrochloride by C.D.M.A., Inc., establishing a generic pe…

• FDA approval · 2010-01-25
  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.

• FDA approval · 2010-01-25
  FDA Approved: CLARITIN-D 24 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for CLARITIN-D 24 HOUR (loratadine and pseudoephedrine sulfate) from Bayer HealthCare LLC. The actio…

• FDA approval · 2010-01-21
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals' original application for cetirizine hydrochloride, granting a generic version of cetirizine for all…

• FDA approval · 2009-12-30
  FDA Approved: CLARINEX-D 12 HOUR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for CLARINEX-D 12 HOUR, a combination of desloratadine and pseudoephedrine sulfate, manufactured by …

• FDA approval · 2009-11-12
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved cetirizine hydrochloride under an original application for use as a generic antihistamine indicated for allergic rhinitis and u…

• FDA approval · 2009-10-07
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved a generic cetirizine hydrochloride product under an Original Abbreviated New Drug Application by Amneal Pharmaceuticals LLC.

• FDA approval · 2009-10-07
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' cetirizine hydrochloride as an Original Application (ANDA090765), establishing a generic cetirizine pro…

• FDA approval · 2009-08-31
  FDA Approved: GOOD NEIGHBOR PHARMACY CHILDRENS LORATADINE — Supplemental Application (AmerisourceBergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Children's Loratadine (loratadine) submitted by AmerisourceBergen.

• FDA approval · 2009-08-26
  FDA Approved: ALLERGY RELIEF — Original Application (Prodose, Inc)

  FDA approved an original application for ALLERGY RELIEF containing cetirizine hydrochloride, marketed by Prodose, Inc.

• FDA approval · 2009-08-25
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' original application for a generic Promethazine hydrochloride and phenylephrine hydrochloride product.

• FDA approval · 2009-08-21
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  FDA has approved a supplemental application for XYZAL (levocetirizine dihydrochloride) submitted by Chattem, Inc., effectively granting appr…

• FDA approval · 2009-08-19
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Singulair (montelukast) submitted by Organon LLC.

• FDA approval · 2009-08-03
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s azelastine hydrochloride generic under an Original Application.

• FDA approval · 2009-07-30
  FDA Approved: NASAL ALLERGY — Original Application (Kroger Company)

  FDA approved NASAL ALLERGY with triamcinolone acetonide from Kroger Company as an Original Application (ANDA 078104) for allergic rhinitis.

• FDA approval · 2009-07-28
  FDA Approved: FLONASE SENSIMIST ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Flonase Sensimist Allergy Relief (fluticasone furoate) from Haleon US Holdings LLC. The approval…

• FDA approval · 2009-06-10
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for diphenhydramine hydrochloride (PAI Pharma) under an ANDA.

• FDA approval · 2009-05-28
  FDA Approved: ALLERGY RELIEF CHILDRENS — Supplemental Application (CVS Pharmacy)

  FDA approved a supplemental application for ALLERGY RELIEF CHILDRENS containing cetirizine hydrochloride by CVS Pharmacy.

• FDA approval · 2009-05-28
  FDA Approved: CHILDRENS CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Children's Cetirizine Hydrochloride from Sun Pharmaceutical Industries, Inc., under an ANDA subm…

• FDA approval · 2009-05-19
  FDA Approved: ADVIL ALLERGY SINUS — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Advil Allergy Sinus, a multi-ingredient combination product from Haleon US Holdings LLC.