Allergic Rhinitis

• EMA approval · 2022-06-09
  EMA Authorised: Desloratadine Teva (desloratadine) — Teva B.V

  The EMA authorised Desloratadine Teva (desloratadine) for allergic rhinitis (perennial and seasonal) with Teva B.V. as the marketing authori…

• FDA approval · 2022-05-31
  FDA Approved: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE — Original Application (Walgreens Company)

  FDA approved Walgreens' generic combination tablet of fexofenadine hydrochloride and pseudoephedrine hydrochloride under an original ANDA fo…

• FDA approval · 2022-05-17
  FDA Approved: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Dr. Reddy's Laboratories' generic combination product of fexofenadine HCl and pseudoephedrine HC…

• FDA approval · 2022-03-17
  FDA Approved: RUGBY MOMETASONE FUROATE NASAL — Original Application (Rugby Laboratories)

  FDA approved Rugby Mometasone Furoate Nasal from Rugby Laboratories under an original NDA. The nasal corticosteroid is indicated for allergi…

• FDA approval · 2022-01-13
  FDA Approved: RYALTRIS — Original Application (HIKMA SPECIALTY USA INC.)

  FDA approved the original application for RYALTRIS, a fixed-dose nasal spray combining olopatadine HCl and mometasone furoate by Hikma Speci…

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• FDA approval · 2021-12-14
  FDA Approved: ZYRTEC — Supplemental Application (Kenvue Brands LLC)

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

• FDA approval · 2021-11-23
  FDA Approved: ADVIL ALLERGY SINUS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Advil Allergy Sinus, a combination product containing chlorpheniramine maleate, ibuprofen, and p…

• FDA approval · 2021-11-03
  FDA Approved: ZYRTEC-D — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC-D (cetirizine hydrochloride and pseudoephedrine hydrochloride) from Kenvue Brands LLC, au…

• FDA approval · 2021-11-01
  FDA Approved: ASTEPRO ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for AStepro Allergy (azelastine HCl) from Bayer HealthCare LLC, resulting in updated labeling for th…

• FDA approval · 2021-10-15
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA has approved a supplemental application for montelukast sodium submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2021-10-15
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Torrent Pharmaceuticals Limited's Montelukast Sodium under ANDA 201515, clearing regulatory appr…

• FDA approval · 2021-07-30
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Aurobindo Pharma Limited to market Montelukast sodium as a generic product.

• FDA approval · 2021-07-12
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved promethazine hydrochloride under an original ANDA for Quagen Pharmaceuticals LLC.

• FDA approval · 2021-06-17
  FDA Approved: ASTEPRO ALLERGY — Original Application (Bayer HealthCare LLC.)

  FDA approved ASTEPRO ALLERGY (azelastine hydrochloride) under Bayer HealthCare LLC.'s original NDA, establishing its intranasal antihistamin…

• 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 · 2021-04-30
  FDA Approved: AZELASTINE HYDROCHLORIDE — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approved a supplemental application for azelastine hydrochloride submitted by Somerset Therapeutics, LLC.

• FDA approval · 2021-04-30
  FDA Approved: AZELASTINE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approves a supplemental application for azelastine submitted by Ascend Laboratories, LLC.

• FDA approval · 2021-04-16
  FDA Approved: DYMISTA — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DYMISTA (azelastine hydrochloride and fluticasone propionate) submitted by Viatris Specialty LLC…

• FDA approval · 2021-04-02
  FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add a chewable grape and bubblegum formulation of loratadine (Claritin) by Bayer HealthCare LLC.

• FDA approval · 2021-03-25
  FDA Approved: CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION — Supplemental Application (Neos Therapeutics, LP)

  FDA approved a supplemental application to authorize an extended-release oral suspension formulation of carbinoxamine maleate, submitted by …

• FDA approval · 2021-03-17
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Children's Allegra Allergy to update its labeling for fexofenadine HCl, marketed by Chattem,…

• FDA approval · 2021-02-22
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA has approved a supplemental application for Singulair (montelukast) from Organon LLC.

• FDA approval · 2021-02-18
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for olopatadine hydrochloride, updating an already-approved product. The appr…

• FDA approval · 2021-02-18
  FDA Approved: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved Padagis Israel Pharmaceuticals' azelastine hydrochloride and fluticasone propionate nasal spray as an original ANDA, provid…

• FDA approval · 2021-01-29
  FDA Approved: MONTELUKAST — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Montelukast from XLCare Pharmaceuticals Inc., approving changes to the generic product under…