Allergic Rhinitis

• 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 · 2019-10-03
  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.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2019-09-06
  FDA Approved: ADVIL ALLERGY AND CONGESTION RELIEF — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for ADVIL ALLERGY AND CONGESTION RELIEF to update its labeling. The product combines chlorpheniramin…

• 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 · 2019-08-09
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC.

• 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 · 2019-06-12
  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…

• 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 · 2019-04-17
  FDA Approved: ALLERGY RELIEF — Original Application (CVS PHARMACY, INC)

  FDA approves CVS Pharmacy, Inc.'s original ANDA for an allergy relief product containing fluticasone propionate.

• 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 · 2019-03-29
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original application for azelastine hydrochloride from Somerset Therapeutics, LLC, enabling the generic product.

• 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 · 2019-03-25
  FDA Approved: AZELASTINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA has approved a supplemental application for azelastine hydrochloride by Amneal Pharmaceuticals LLC.

• FDA approval · 2019-03-15
  FDA Approved: CLARINEX-D 12 HOUR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for CLARINEX-D 12 HOUR, a desloratadine and pseudoephedrine sulfate combination, from Organon LLC.

• 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 · 2019-02-28
  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 · 2019-02-21
  FDA Approved: PREDNISONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for prednisone from Mylan Pharmaceuticals, indicating approval of an existing generic product's …

• FDA approval · 2019-01-31
  FDA Approved: PHENYLEPHRINE HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved an Original Application for Phenylephrine Hydrochloride from Sandoz Inc, enabling the marketing of this generic product.