Idiopathic Urticaria

• FDA approval · 2021-05-07
  FDA Approved: LORATADINE — Original Application (Camber Consumer Care Inc)

  The FDA approved Camber Consumer Care Inc's loratadine product under an Original Application, marking the approval of this generic antihista…

• FDA approval · 2020-09-10
  FDA Approved: LORATADINE — Original Application (Advagen Pharma Limited)

  FDA approved Advagen Pharma Limited's original ANDA for loratadine, a generic antihistamine indicated for allergic rhinitis and chronic idio…

• FDA approval · 2020-03-05
  FDA Approved: LORATADINE — Supplemental Application (Wal-Mart Stores, Inc)

  FDA approved a supplemental application for loratadine submitted by Wal-Mart Stores, Inc., updating an already approved product under ANDA21…

• FDA approval · 2019-12-23
  FDA Approved: LORATADINE — Original Application (GRANULES USA, INC.)

  FDA approved Granules USA, Inc.'s loratadine Original Application, granting a generic loratadine tablet product.

• FDA approval · 2019-10-22
  FDA Approved: DESLORATADINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approves a supplemental application for desloratadine submitted by Dr. Reddy's Laboratories Limited.

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• FDA approval · 2019-10-22
  FDA Approved: DESLORATADINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for desloratadine, a generic antihistamine used to treat allergy symptoms.

• FDA approval · 2019-10-21
  FDA Approved: GOOD SENSE LEVOCETIRIZINE — Supplemental Application (L. Perrigo Company)

  FDA approved a supplemental application for Good Sense Levocetirizine (levocetirizine dihydrochloride) from L. Perrigo Company.

• FDA approval · 2019-10-18
  FDA Approved: DESLORATADINE — Supplemental Application (Bionpharma Inc.)

  FDA approves a supplemental application for Desloratadine from Bionpharma Inc., confirming the approval of the generic product under ANDA 07…

• FDA approval · 2019-10-18
  FDA Approved: ALLERGY RELIEF — Original Application (WALMART INC. (see also Equate))

  The FDA approved Walmart's original application for an over-the-counter allergy relief product containing fexofenadine hydrochloride (Allerg…

• FDA approval · 2019-10-03
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Claritin Chewable Grape and Bubble Gum (loratadine) by Bayer HealthCare LLC, adding a flavor…

• FDA approval · 2019-10-03
  FDA Approved: DESLORATADINE — Supplemental Application (Natco Pharma USA LLC)

  The FDA approved a supplemental application for desloratadine from Natco Pharma USA LLC.

• FDA approval · 2019-09-23
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

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

• FDA approval · 2019-06-28
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for levocetirizine dihydrochloride (Camber Pharmaceuticals, Inc.). The approval updates the product'…

• FDA approval · 2019-05-07
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  The FDA approved a supplemental application for CLARITIN REDITABS (loratadine) from Bayer Healthcare LLC., likely authorizing a new or modif…

• FDA approval · 2019-03-28
  FDA Approved: GOOD SENSE LEVOCETIRIZINE — Original Application (L. Perrigo Company)

  The FDA approved the original application for Good Sense Levocetirizine (levocetirizine dihydrochloride) by L. Perrigo Company as a generic …

• FDA approval · 2019-02-28
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer HealthCare LLC)

  The FDA approved a supplemental application for Claritin RediTabs (loratadine) from Bayer HealthCare LLC. The action adds a new formulation …

• FDA approval · 2019-02-28
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  The FDA approved a supplemental application for Claritin RediTabs containing loratadine, introducing a new dosage form under Bayer Healthcar…

• FDA approval · 2018-11-21
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Claritin Chewable Grape and Bubblegum (loratadine) as a new chewable dosage form, expanding t…

• FDA approval · 2018-10-03
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental application for Claritin (loratadine) from Bayer HealthCare LLC. The action approves changes to the product's la…

• FDA approval · 2018-07-20
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Claritin Chewable Grape and Bubblegum (loratadine) from Bayer HealthCare LLC.

• FDA approval · 2018-07-05
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

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

• FDA approval · 2018-05-21
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved a supplemental application for a generic version of levocetirizine dihydrochloride from Dr. Reddy's Laboratories Inc.

• FDA approval · 2018-04-16
  FDA Approved: LORATADINE — Original Application (Chain Drug Consortium, LLC)

  The FDA approved the original application for loratadine filed by Chain Drug Consortium, LLC, enabling a generic loratadine product to be ma…

• FDA approval · 2018-04-11
  FDA Approved: LORATADINE ODT — Original Application (Aurohealth LLC)

  FDA approved a generic loratadine orally disintegrating tablet (LORATADINE ODT) under ANDA 208477 with Aurohealth LLC as the sponsor. The pr…

• FDA approval · 2018-04-02
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for XYZAL (levocetirizine dihydrochloride) filed by Chattem, Inc. The action confirms changes to the…