Urticaria

• FDA approval · 2012-09-10
  FDA Approved: ZYRTEC HIVES — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC HIVES (cetirizine hydrochloride) and finalized its label to cover the treatment of hives …

• FDA approval · 2012-08-23
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Allegra Hives 24HR (fexofenadine hydrochloride) by Chattem, Inc., indicating an update to the pr…

• FDA approval · 2012-08-23
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application to update the labeling for Children's Allegra Allergy (fexofenadine hydrochloride), expanding its pe…

• FDA approval · 2012-06-28
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Cranbury Pharmaceuticals, LLC)

  The FDA approved Promethazine hydrochloride as an original generic drug application (ANDA) for Cranbury Pharmaceuticals, LLC.

• FDA approval · 2012-05-22
  FDA Approved: CHILDRENS ZYRTEC — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Children's Zyrtec (cetirizine hydrochloride) by Kenvue Brands LLC.

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• FDA approval · 2012-02-23
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Allegra Hives 24HR (fexofenadine hydrochloride) submitted by Chattem, Inc., approving the change…

• FDA approval · 2012-02-06
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Original Application (AMERISOURCE BERGEN)

  FDA approved an original application for fexofenadine hydrochloride (a generic antihistamine) with Amerisource Bergen. The product is indica…

• FDA approval · 2012-01-26
  FDA Approved: ZYRTEC HIVES — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC HIVES (cetirizine hydrochloride) to support an expanded indication for the treatment of u…

• FDA approval · 2011-10-01
  FDA Approved: CHILDRENS CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical Industries' Children's Cetirizine Hydrochloride. The action updates the label…

• FDA approval · 2011-08-30
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (OHM LABORATORIES INC.)

  FDA approved the original application for cetirizine hydrochloride by OHM Laboratories, a generic antihistamine. It is used to treat allergi…

• FDA approval · 2011-08-22
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's original generic application for levocetirizine dihydrochloride, enabling market entry for this antihistamine.

• 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 · 2011-04-21
  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.

• 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 · 2011-02-15
  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: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for ALLEGRA HIVES 24HR (fexofenadine hydrochloride) by Chattem, Inc.

• 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 · 2010-09-03
  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 · 2010-07-23
  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 · 2010-06-15
  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…

• 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 · 2010-02-26
  FDA Approved: ZYRTEC HIVES — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for ZYRTEC HIVES (cetirizine hydrochloride) to treat hives (urticaria), expanding its labeled in…

• 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…