Urticaria

• FDA approval · 2019-09-13
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for levocetirizine dihydrochloride from Macleods Pharmaceuticals Limited under ANDA205564.

• FDA approval · 2019-08-29
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Vensun Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for levocetirizine dihydrochloride from Vensun Pharmaceuticals, Inc., finalizing an update to an…

• FDA approval · 2019-06-12
  FDA Approved: CHILDRENS ALLERGY RELIEF — Original Application (H E B)

  FDA approved an original ANDA for Children's Allergy Relief containing loratadine, a generic antihistamine manufactured by H E B.

• FDA approval · 2019-05-22
  FDA Approved: CYPROHEPTADINE HYDROCHLORIDE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved Cyproheptadine hydrochloride from Quagen Pharmaceuticals LLC under an Original Application for a generic product.

• FDA approval · 2019-05-16
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved cetirizine hydrochloride under an original ANDA for QUAGEN PHARMACEUTICALS LLC as an oral antihistamine indicated for relief of…

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• FDA approval · 2019-04-01
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for a generic levocetirizine dihydrochloride product, an antihistamine indicat…

• FDA approval · 2019-03-13
  FDA Approved: CHILDRENS ALLERGY RELIEF — Original Application (Strategic Sourcing Services)

  FDA approves an Original ANDA for Cetirizine Hydrochloride marketed as Children's Allergy Relief from Strategic Sourcing Services.

• FDA approval · 2019-01-03
  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) under the Claritin label, expanding the pr…

• FDA approval · 2018-12-21
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

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

• FDA approval · 2018-12-21
  FDA Approved: LORATADINE — Original Application (Bionpharma Inc.)

  The FDA approved Bionpharma Inc.'s original ANDA for loratadine, authorizing a generic loratadine product to be marketed in the United State…

• FDA approval · 2018-11-20
  FDA Approved: ALLERGY RELIEF 24HR — Original Application (VELOCITY PHARMA LLC)

  FDA approved the original application for Allergy Relief 24HR (levocetirizine dihydrochloride) from Velocity Pharma LLC. It is a generic ant…

• FDA approval · 2018-08-22
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Original Application (Armas Pharmaceuticals Inc.)

  FDA approved the original generic application for diphenhydramine hydrochloride from Armas Pharmaceuticals, making a generic diphenhydramine…

• FDA approval · 2018-08-13
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Original Application (Pioneer Life Sciences, LLC)

  FDA approved a generic version of fexofenadine hydrochloride from Pioneer Life Sciences, LLC under an original ANDA, indicated for allergic …

• FDA approval · 2018-07-23
  FDA Approved: CLARITIN REDITABS — Supplemental Application (Bayer Healthcare LLC.)

  FDA approved a supplemental application for Claritin RediTabs (loratadine) from Bayer, resulting in a labeling update for this product.

• FDA approval · 2018-07-20
  FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application for Claritin Liqui-Gels (loratadine) from Bayer HealthCare LLC.

• FDA approval · 2018-06-29
  FDA Approved: LORATADINE — Original Application (Better Living Brands LLC)

  FDA approves the original ANDA for loratadine oral by Better Living Brands LLC, authorizing its generic product.

• FDA approval · 2018-06-20
  FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application to add CLARITIN LIQUI-GELS (loratadine) as a new dosage form for Claritin. This expands the prod…

• FDA approval · 2018-06-01
  FDA Approved: TOPCARE CHILDRENS ALLERGY — Supplemental Application (Topco Associates LLC)

  The FDA approved a supplemental application for TOPCARE CHILDRENS ALLERGY (loratadine) from Topco Associates LLC, authorizing a labeling upd…

• FDA approval · 2018-05-30
  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 · 2018-05-14
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) from Bayer HealthCare LLC, approving the supplemental action relat…

• FDA approval · 2018-04-18
  FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Claritin Liqui-Gels (loratadine) as a new dosage form in the Claritin product line, manufactu…

• FDA approval · 2018-04-16
  FDA Approved: LORATADINE — Original Application (Wal-Mart Stores, Inc)

  FDA approves Wal-Mart Stores, Inc.'s original ANDA for loratadine (generic antihistamine) to treat allergy symptoms.

• FDA approval · 2018-02-15
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin chewable grape and bubblegum formulations (loratadine) from Bayer HealthCare LLC. This …

• FDA approval · 2018-01-12
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental application for Claritin (loratadine) filed by Bayer HealthCare LLC. This action confirms a supplemental approva…