Idiopathic Urticaria

• FDA approval · 2014-11-18
  FDA Approved: CHILDREN ALLERGY — Original Application (Walgreens)

  FDA approved Walgreens' original application for a pediatric allergy product containing fexofenadine hydrochloride (Children Allergy).

• FDA approval · 2014-11-07
  FDA Approved: LORATADINE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for loratadine from Lannett Company, expanding the availability of this generic antihistamine.

• FDA approval · 2014-09-09
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Vensun Pharmaceuticals, Inc.)

  FDA approved the original application (ANDA) for levocetirizine dihydrochloride by Vensun Pharmaceuticals, Inc., providing a generic version…

• FDA approval · 2014-07-25
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Chewable Grape and Bubblegum containing loratadine, expanding the product line with a n…

• FDA approval · 2014-05-12
  FDA Approved: DESLORATADINE — Supplemental Application (Virtus Pharmaceuticals, LLC)

  FDA approved a supplemental application for desloratadine from Virtus Pharmaceuticals, LLC.

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• FDA approval · 2013-11-29
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA granted a supplemental approval for Levocetirizine dihydrochloride by Teva Pharmaceuticals USA, Inc. (generic) under an ANDA supplement.

• FDA approval · 2013-09-17
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Marlex Pharmaceuticals Inc)

  FDA approved levocetirizine dihydrochloride under an original application for a generic antihistamine indicated for relief of symptoms of al…

• FDA approval · 2013-09-04
  FDA Approved: CAREONE ALLERGY RELIEF — Supplemental Application (American Sales Company)

  FDA approved a supplemental application for CAREONE ALLERGY RELIEF (fexofenadine HCl) from American Sales Company; this pertains to the supp…

• FDA approval · 2013-07-23
  FDA Approved: CLARINEX — Supplemental Application (Organon LLC)

  FDA has approved a supplemental application for CLARINEX (desloratadine) submitted by Organon LLC.

• FDA approval · 2013-06-05
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

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

• FDA approval · 2013-02-05
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark Pharmaceuticals Inc., USA's supplemental application for levocetirizine dihydrochloride, a generic antihistamine u…

• FDA approval · 2013-01-30
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Camber Pharmaceuticals' generic levocetirizine dihydrochloride.

• FDA approval · 2013-01-02
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The U.S. FDA approved a supplemental application for fexofenadine hydrochloride from Dr. Reddy's Laboratories Limited.

• FDA approval · 2012-11-29
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Dr.Reddy's laboratories Ltd.)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Dr. Reddy's Laboratories Ltd., granting approval to an exist…

• FDA approval · 2012-11-29
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Levocetirizine Dihydrochloride from Camber Pharmaceuticals, Inc.

• FDA approval · 2012-11-20
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) submitted by Chattem, Inc. The approval updates the d…

• FDA approval · 2012-11-16
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

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

• FDA approval · 2012-06-29
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for levocetirizine dihydrochloride, a generic antihistamine. It is indicated for a…

• FDA approval · 2012-05-11
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.)

  The FDA approved the original ANDA for cetirizine hydrochloride (oral solution) from Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals La…

• FDA approval · 2012-04-19
  FDA Approved: DESLORATADINE — Original Application (Virtus Pharmaceuticals, LLC)

  The FDA approved Virtus Pharmaceuticals, LLC’s generic desloratadine via an Original Application (ANDA). This adds a generic option for desl…

• FDA approval · 2012-02-10
  FDA Approved: DESLORATADINE — Original Application (Natco Pharma USA LLC)

  FDA approved an original application for a desloratadine generic from Natco Pharma USA LLC.

• FDA approval · 2011-11-18
  FDA Approved: DESLORATADINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for desloratadine submitted by Dr. Reddy's Laboratories Limited, marking an approval of changes …

• FDA approval · 2011-11-07
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approves the original application for levocetirizine dihydrochloride from Padagis Israel Pharmaceuticals Ltd, a generic antihistamine.

• FDA approval · 2011-09-23
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for fexofenadine hydrochloride from Dr. Reddy's Laboratories Limited, enabling the generic produ…

• 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.