Urticaria

• FDA approval · 2014-09-26
  FDA Approved: ZYRTEC HIVES — Supplemental Application (Kenvue Brands LLC)

  FDA approves a supplemental application for ZYRTEC HIVES (cetirizine hydrochloride) submitted by Kenvue Brands LLC. This action expands the …

• FDA approval · 2014-09-12
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Allegra Hives 24HR (fexofenadine hydrochloride) submitted by Chattem, Inc., likely updating …

• FDA approval · 2014-08-19
  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. The approval i…

• FDA approval · 2014-07-22
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental NDA for Claritin RediTabs (loratadine) by Bayer HealthCare LLC.

• FDA approval · 2014-07-22
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  FDA approved a supplemental application for Claritin RediTabs (loratadine) from Bayer Healthcare LLC, updating the approved formulation. Lor…

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• FDA approval · 2014-06-05
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Hydroxyzine Hydrochloride from Teva Pharmaceuticals USA, Inc., granting regulatory clearance…

• FDA approval · 2014-06-04
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for hydroxyzine hydrochloride, authorizing changes to the approved produc…

• FDA approval · 2014-06-03
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for hydroxyzine hydrochloride filed by Northstar RxLLC, enabling regulatory clearance related to the…

• FDA approval · 2014-06-03
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for hydroxyzine hydrochloride (HYDROXYZINE HYDROCHLORIDE) from Chartwell RX, LLC.

• FDA approval · 2014-05-16
  FDA Approved: CHILDRENS ZYRTEC — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for CHILDRENS ZYRTEC (cetirizine hydrochloride) submitted by Kenvue Brands LLC.

• FDA approval · 2014-05-15
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) by Bayer HealthCare LLC. The filing relates to labeling and/or ind…

• FDA approval · 2014-04-23
  FDA Approved: CLARINEX — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for CLARINEX (desloratadine) from Organon LLC.

• FDA approval · 2014-04-16
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for ALLEGRA HIVES 24HR (fexofenadine hydrochloride) from Chattem, Inc., authorizing an approved chan…

• FDA approval · 2014-02-24
  FDA Approved: ZYRTEC ALLERGY — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC ALLERGY (cetirizine hydrochloride) from Kenvue Brands LLC, likely for labeling or indicat…

• FDA approval · 2014-02-21
  FDA Approved: ZYRTEC ALLERGY — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC ALLERGY (cetirizine hydrochloride) submitted by Kenvue Brands LLC.

• FDA approval · 2014-01-31
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Children's Allegra Allergy (fexofenadine hydrochloride) from Chattem, Inc., resulting in labelin…

• FDA approval · 2014-01-26
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for Allergy Relief containing loratadine from Ohm Laboratories Inc., indicating a regulatory update …

• FDA approval · 2013-09-09
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Prodose, Inc)

  FDA approved a supplemental application for ALLERGY RELIEF containing cetirizine hydrochloride, submitted by Prodose, Inc.

• FDA approval · 2013-06-03
  FDA Approved: HYDROXYZINE PAMOATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved hydroxyzine pamoate as a generic drug under an Original Application by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuti…

• FDA approval · 2013-05-28
  FDA Approved: CHILDRENS CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Children's Cetirizine Hydrochloride from Sun Pharmaceutical Industries, Inc. This action exp…

• FDA approval · 2013-04-16
  FDA Approved: ALLEGRA HIVES 24HR — Supplemental Application (Chattem, Inc.)

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

• FDA approval · 2013-03-26
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved Bayer's supplemental application to add a Claritin chewable grape and bubblegum formulation containing loratadine. This exp…

• FDA approval · 2013-02-28
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved Bayer HealthCare LLC's supplemental application for Claritin Allergy (loratadine). This action covers changes related to th…

• FDA approval · 2013-01-04
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add a grape and bubblegum flavor for Claritin chewable (loratadine) manufactured by Bayer HealthC…

• FDA approval · 2012-12-30
  FDA Approved: PROMETHEGAN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Cosette Pharmaceuticals' PROMETHEGAN (promethazine hydrochloride), updating its labeling und…