Allergic Rhinitis

• FDA approval · 2008-04-22
  FDA Approved: CHILDRENS CETIRIZINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved the original application for Sun Pharmaceutical's Children's cetirizine hydrochloride, a generic cetirizine product for pediatr…

• FDA approval · 2008-04-21
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2008-04-09
  FDA Approved: ALLERGY RELIEF CHILDRENS — Original Application (CVS Pharmacy)

  FDA approved a pediatric cetirizine hydrochloride product under an original application for Allergy Relief Childrens (CVS Pharmacy).

• FDA approval · 2008-03-07
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) by Organon LLC, updating the product labeling.

• FDA approval · 2008-03-07
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved Organon LLC's supplemental application for Singulair (montelukast), leading to updated labeling for the product. This actio…

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• FDA approval · 2008-03-03
  FDA Approved: GOOD NEIGHBOR PHARMACY CHILDRENS LORATADINE — Supplemental Application (AmerisourceBergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Children's Loratadine (loratadine) from AmerisourceBergen, indicating app…

• FDA approval · 2008-02-26
  FDA Approved: ASMANEX — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ASMANEX (mometasone furoate) submitted by Organon LLC to update the product labeling. The action…

• FDA approval · 2008-02-14
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved the original application for cetirizine hydrochloride from Sandoz Inc., a generic antihistamine used to treat allergic rhinitis…

• FDA approval · 2008-02-01
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) filed by Chattem, Inc., indicating an approved update…

• FDA approval · 2008-01-15
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved the original ANDA for cetirizine hydrochloride tablets from Dr. Reddy's Laboratories Limited, marking the approval of a generic…

• FDA approval · 2008-01-10
  FDA Approved: ALVESCO — Original Application (Covis Pharma US, Inc)

  The FDA approved ALVESCO (ciclesonide) nasal spray from Covis Pharma US, Inc. through an original NDA (NDA021658) for the treatment of aller…

• FDA approval · 2007-12-31
  FDA Approved: CAREONE ALLERGY RELIEF — Supplemental Application (American Sales Company)

  FDA approved a supplemental application for CAREONE ALLERGY RELIEF (fexofenadine hydrochloride) under ANDA076447, filed by American Sales Co…

• FDA approval · 2007-12-28
  FDA Approved: CETIRIZINE HCL — Original Application (GLENMARK THERAPEUTICS INC., USA)

  FDA approved Glenmark's cetirizine HCl Original Application (ANDA), granting marketing rights for a generic cetirizine product. Indications …

• FDA approval · 2007-12-27
  FDA Approved: ALL DAY ALLERGY RELIEF — Original Application (Dolgencorp, Inc. (DOLLAR GENERAL & REXALL))

  FDA approved ALL DAY ALLERGY RELIEF (cetirizine hydrochloride) from Dolgencorp as an original application for an over-the-counter antihistam…

• FDA approval · 2007-12-27
  FDA Approved: ALLERGY RELIEF — Original Application (Allegiant Health)

  The FDA approved a generic cetirizine HCl 10 mg tablet under Allegiant Health (ANDA078317) for allergy relief.

• FDA approval · 2007-12-27
  FDA Approved: BETR REMEDIES ALL DAY ALLERGY RELIEF — Original Application (Live Betr LLC)

  FDA approved a new generic version of cetirizine hydrochloride under BETR REMEDIES ALL DAY ALLERGY RELIEF for over-the-counter allergy relie…

• FDA approval · 2007-12-27
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Ohm Laboratories Inc.)

  FDA approved cetirizine hydrochloride as a generic oral antihistamine under an original application for Ohm Laboratories Inc., for relief of…

• FDA approval · 2007-12-27
  FDA Approved: CETIRIZINE HCL — Original Application (GERI-CARE PHARMACEUTICAL CORP)

  FDA approved the original application for cetirizine hydrochloride 10 mg (cetirizine HCl) for use in treating allergic rhinitis and urticari…

• FDA approval · 2007-12-27
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan Pharmaceuticals' original ANDA for cetirizine hydrochloride, a generic antihistamine used to treat allergic rhinitis and …

• FDA approval · 2007-12-20
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental application for Claritin (loratadine) filed by Bayer HealthCare LLC.

• FDA approval · 2007-11-21
  FDA Approved: OMNARIS — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Omnaris (ciclesonide) submitted by Covis Pharma US, Inc., authorizing an update to the produ…

• FDA approval · 2007-11-16
  FDA Approved: CHILDRENS ZYRTEC — Original Application (Kenvue Brands LLC)

  FDA approved an original application for Children's Zyrtec (cetirizine hydrochloride) developed by Kenvue Brands LLC.

• FDA approval · 2007-11-09
  FDA Approved: ZYRTEC-D — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for ZYRTEC-D (cetirizine hydrochloride and pseudoephedrine hydrochloride) by Kenvue Brands LLC.

• FDA approval · 2007-10-18
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

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

• FDA approval · 2007-09-12
  FDA Approved: FLUTICASONE PROPIONATE — Original Application (Golden State Medical Supply, Inc.)

  FDA approved the original application for Fluticasone Propionate, submitted by Golden State Medical Supply, Inc.