Allergic Rhinitis

• FDA approval · 2011-06-23
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for budesonide from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2011-06-22
  FDA Approved: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for a generic combination tablet of fexofenadine HCl and pseudoephedrine HCl (ANDA 079043) to Dr. Re…

• FDA approval · 2011-05-20
  FDA Approved: CHILDRENS ALLERGY — Original Application (Publix Super Markets Inc)

  FDA approves an original ANDA for a pediatric cetirizine hydrochloride product marketed as CHILDRENS ALLERGY by Publix Super Markets Inc, ex…

• FDA approval · 2011-04-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC, resulting in updated labeling for the p…

• FDA approval · 2011-04-21
  FDA Approved: GOOD NEIGHBOR PHARMACY CHILDRENS LORATADINE — Supplemental Application (AmerisourceBergen)

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

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• FDA approval · 2011-04-13
  FDA Approved: CAREONE ALLERGY RELIEF — Supplemental Application (American Sales Company)

  The FDA approved a supplemental application for CAREONE ALLERGY RELIEF containing fexofenadine HCl, submitted by American Sales Company. Thi…

• FDA approval · 2011-04-12
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for Dr. Reddy's Laboratories' generic fexofenadine hydrochloride, granting its approval as a gen…

• FDA approval · 2011-03-07
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) submitted by Chattem, Inc.

• FDA approval · 2011-02-24
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Dr.Reddy's laboratories Ltd.)

  FDA approved Dr. Reddy's Laboratories' original application for levocetirizine dihydrochloride, a generic antihistamine. The approval covers…

• FDA approval · 2011-02-24
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's original application for levocetirizine dihydrochloride, a generic antihistamine.

• FDA approval · 2011-02-15
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for cetirizine hydrochloride from Ohm Laboratories, enabling its cetirizine hydrochloride product to…

• FDA approval · 2011-01-24
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for CHILDRENS ALLEGRA ALLERGY (fexofenadine hydrochloride) submitted by Chattem, Inc., typically to …

• FDA approval · 2011-01-24
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Allegra-D Allergy and Congestion, containing fexofenadine hydrochloride and pseudoephedrine hydr…

• FDA approval · 2011-01-24
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Original Application (Chattem, Inc.)

  FDA approves the pediatric formulation of Allegra Allergy (fexofenadine hydrochloride) for children under the original application, enabling…

• FDA approval · 2011-01-24
  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 of fexofenadine hydrochloride and pseudo…

• FDA approval · 2010-12-13
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals' original application for generic promethazine hydrochloride, enabling the sale of a generic antihis…

• FDA approval · 2010-10-25
  FDA Approved: DESLORATADINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original ANDA for desloratadine, a non-sedating antihistamine used to treat allergic rhinitis and urtica…

• FDA approval · 2010-10-01
  FDA Approved: HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approved the original application for Hydrocodone polistirex and chlorpheniramine polistirex extended-release, a fixed-dose combination …

• FDA approval · 2010-09-03
  FDA Approved: ZYRTEC ALLERGY — Original Application (Kenvue Brands LLC)

  FDA approved ZYRTEC ALLERGY (cetirizine hydrochloride) from Kenvue Brands LLC under an Original Application.

• FDA approval · 2010-08-31
  FDA Approved: ADVIL ALLERGY SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Allergy Sinus (chlorpheniramine maleate, ibuprofen, and pseudoephedrine HCl) from Haleon U…

• FDA approval · 2010-07-23
  FDA Approved: ALLERGY RELIEF CHILDRENS — Supplemental Application (CVS Pharmacy)

  FDA approved a supplemental application for Allergy Relief Children's cetirizine hydrochloride from CVS Pharmacy, indicating an approved mod…

• FDA approval · 2010-07-12
  FDA Approved: DESLORATADINE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Desloratadine from Dr. Reddy's Laboratories Limited as an original ANDA, making a generic desloratadine available for use in al…

• FDA approval · 2010-06-29
  FDA Approved: KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE — Supplemental Application (Kirkland-COSTCO WHOLESALE COMPANY)

  FDA granted supplemental approval for Kirkland Signature Allerclear D 24 HR Extended Release, a loratadine and pseudoephedrine sulfate combi…

• FDA approval · 2010-06-21
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved the original ANDA for azelastine hydrochloride nasal spray from Sun Pharmaceutical Industries, enabling a generic version. …

• FDA approval · 2010-06-15
  FDA Approved: ALLERGY RELIEF — Original Application (WALGREENS)

  FDA approved Walgreens' ALLERGY RELIEF as an original ANDA for cetirizine hydrochloride, establishing a generic antihistamine option. The pr…