Allergic Rhinitis

• FDA approval · 2016-11-08
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for cetirizine hydrochloride submitted by Rising Pharma Holdings, Inc. under an ANDA.

• FDA approval · 2016-11-04
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  The FDA approved a supplemental application for Claritin RediTabs (loratadine) submitted by Bayer Healthcare LLC, under the existing NDA.

• FDA approval · 2016-10-31
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Allegra-D Allergy and Congestion, a combination product from Chattem, Inc. containing fexofenadi…

• FDA approval · 2016-10-31
  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 · 2016-10-26
  FDA Approved: TRIAMCINOLONE ACETONIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA granted approval of a supplemental application for Triamcinolone Acetonide submitted by Sun Pharmaceutical Industries, Inc., resulting i…

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• FDA approval · 2016-09-23
  FDA Approved: LORATADINE — Original Application (MARKSANS PHARMA LIMITED)

  FDA approved loratadine via an Original Application (ANDA) for Marksans Pharma Limited, expanding access to a generic antihistamine.

• FDA approval · 2016-08-25
  FDA Approved: TUXARIN — Supplemental Application (Mainpointe Pharmaceuticals)

  FDA approved a supplemental application for TUXARIN (codeine phosphate and chlorpheniramine maleate) from Mainpointe Pharmaceuticals. The ap…

• FDA approval · 2016-08-12
  FDA Approved: CAREONE ALLERGY RELIEF — Original Application (American Sales Company)

  FDA approved CAREONE ALLERGY RELIEF as an original application for cetirizine hydrochloride tablets (generic antihistamine) from American Sa…

• FDA approval · 2016-08-09
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Claritin Allergy (loratadine) from Bayer HealthCare LLC.

• FDA approval · 2016-08-05
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Children's Allegra Allergy (fexofenadine hydrochloride) to modify the labeling related to pe…

• FDA approval · 2016-08-02
  FDA Approved: FLONASE SENSIMIST ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Flonase Sensimist Allergy Relief containing fluticasone furoate, filed by Haleon US Holdings…

• FDA approval · 2016-06-16
  FDA Approved: CLARINEX — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for CLARINEX (desloratadine) submitted by Organon LLC. The action confirms regulatory approval relat…

• FDA approval · 2016-06-15
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Children's Allegra Allergy (fexofenadine hydrochloride) submitted by Chattem, Inc.

• FDA approval · 2016-06-10
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Children's Allegra Allergy (fexofenadine hydrochloride) from Chattem, Inc., marking an additiona…

• FDA approval · 2016-06-02
  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 · 2016-06-02
  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 · 2016-05-31
  FDA Approved: RYVENT — Original Application (Carwin Pharmaceutical Associates, LLC)

  FDA approved Ryvent (carbinoxamine maleate) in relation to its original application for this generic antihistamine from Carwin Pharmaceutica…

• FDA approval · 2016-05-26
  FDA Approved: DESLORATADINE ORAL SOLUTION — Original Application (INA Pharmaceutics, Inc.)

  INA Pharmaceutics' Desloratadine oral solution received FDA approval as a generic version of desloratadine for allergic rhinitis and chronic…

• FDA approval · 2016-05-12
  FDA Approved: CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION — Supplemental Application (Neos Therapeutics, LP)

  FDA approved a supplemental application to authorize a new extended-release oral suspension formulation of carbinoxamine maleate by Neos The…

• FDA approval · 2016-04-29
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for budesonide. The action reflects changes to the product's labeling…

• FDA approval · 2016-04-19
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Unichem Pharmaceuticals (USA), Inc., under the ANDA.

• FDA approval · 2016-04-05
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

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

• FDA approval · 2016-03-23
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Allegra Hives 24HR (fexofenadine hydrochloride) from Chattem, Inc., supporting the product's use…

• FDA approval · 2016-03-22
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Nasacort Allergy 24HR (triamcinolone acetonide nasal spray) from Chattem, Inc., updating its lab…

• FDA approval · 2016-03-09
  FDA Approved: ZYRTEC-D — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for ZYRTEC-D, a combination of cetirizine hydrochloride and pseudoephedrine hydrochloride, submi…