Allergic Rhinitis

• FDA approval · 2018-02-26
  FDA Approved: ADVIL ALLERGY AND CONGESTION RELIEF — Supplemental Application (Haleon US Holdings LLC)

  FDA approves a supplemental application to market ADVIL ALLERGY AND CONGESTION RELIEF, a fixed-dose combination product containing chlorphen…

• 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 · 2018-02-06
  FDA Approved: CLARINEX-D 12 HOUR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for CLARINEX-D 12 HOUR, a desloratadine and pseudoephedrine sulfate combination product from Org…

• FDA approval · 2018-01-19
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for NASACORT ALLERGY 24HR (Triamcinolone Acetonide) from Chattem, Inc.

• FDA approval · 2018-01-19
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved Dr. Reddy's Laboratories' original ANDA for levocetirizine dihydrochloride, a generic antihistamine indicated for relief of…

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• 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…

• FDA approval · 2017-12-29
  FDA Approved: GUAIFENESIN AND PSEUDOEPHEDRINE HCL — Original Application (Dr. Reddys Laboratories Limited)

  FDA approved an original ANDA for guaifenesin and pseudoephedrine hydrochloride tablets from Dr. Reddys Laboratories Limited, establishing a…

• FDA approval · 2017-12-27
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Vensun Pharmaceuticals, Inc.)

  FDA approved a supplemental application for levocetirizine dihydrochloride (Vensun Pharmaceuticals, Inc.) under an ANDA. This action maintai…

• FDA approval · 2017-12-22
  FDA Approved: CURIST ALLERGY RELIEF — Original Application (Little Pharma, Inc.)

  FDA approves CURIST ALLERGY RELIEF through an original ANDA for cetirizine hydrochloride, authorizing the generic for allergy symptom relief…

• FDA approval · 2017-11-09
  FDA Approved: CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY — Original Application (Wal-Mart Stores Inc)

  FDA approved a generic version of fexofenadine hydrochloride for pediatric allergy uses under an Original Application with Wal-Mart Stores I…

• FDA approval · 2017-10-30
  FDA Approved: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE — Original Application (Aurohealth LLC)

  FDA approved Aurohealth LLC’s original ANDA for a combination tablet containing fexofenadine hydrochloride and pseudoephedrine hydrochloride…

• FDA approval · 2017-10-20
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Selder, S.A. de C.V.)

  FDA approved a supplemental application for Fluticasone Propionate nasal spray by Selder for allergy relief.

• FDA approval · 2017-10-17
  FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for Budesonide submitted by Padagis US LLC, expanding regulatory authorization for the product. The …

• FDA approval · 2017-10-12
  FDA Approved: MOMETASONE FUROATE — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved Cosette Pharmaceuticals, Inc.'s supplemental application for mometasone furoate.

• FDA approval · 2017-09-18
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental ANDA for levocetirizine dihydrochloride from Teva Pharmaceuticals USA, Inc., expanding the availability of a gen…

• FDA approval · 2017-09-18
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Levocetirizine dihydrochloride by Macleods Pharmaceuticals Limited under ANDA205564.

• FDA approval · 2017-09-15
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Supplemental Application (7-eleven)

  FDA approved a supplemental application for fexofenadine hydrochloride (ANDA 202039) submitted by 7-eleven.

• FDA approval · 2017-08-31
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals Inc)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Marlex Pharmaceuticals, updating an existing approved produc…

• FDA approval · 2017-08-31
  FDA Approved: CHILDRENS FLONASE ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Children's Flonase Allergy Relief (fluticasone propionate) submitted by Haleon US Holdings LLC.

• FDA approval · 2017-08-29
  FDA Approved: PROMETHAZINE AND PHENYLEPHRINE HCL, AND CODEINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for a generic combination product containing promethazine, phenylephrine, and codeine phosphate manu…

• FDA approval · 2017-08-28
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's azelastine hydrochloride as a generic product under an original ANDA.

• FDA approval · 2017-08-23
  FDA Approved: FLONASE SENSIMIST ALLERGY RELIEF — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Flonase Sensimist Allergy Relief (fluticasone furoate) to expand the label for allergy relie…

• FDA approval · 2017-08-18
  FDA Approved: AZELASTINE — Original Application (Ascend Laboratories, LLC)

  The FDA approved the original application for azelastine, a generic antihistamine, submitted by Ascend Laboratories, LLC.

• FDA approval · 2017-07-31
  FDA Approved: BUDESONIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's original application for budesonide (generic). Budesonide is a corticosteroid used to …

• FDA approval · 2017-07-21
  FDA Approved: ALLERGY RELIEF — Original Application (WALMART INC. (see also Equate))

  FDA approved Walmart's ALLERGY RELIEF containing cetirizine hydrochloride as an original generic application (ANDA 205291) for allergy relie…