Allergic Rhinitis

• FDA approval · 2025-05-09
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for NASACORT ALLERGY 24HR (triamcinolone acetonide) from Chattem, Inc. This action represents a supp…

• FDA approval · 2025-04-17
  FDA Approved: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE — Original Application (Aurohealth LLC)

  FDA approved the original ANDA for a generic fixed-dose combination of fexofenadine hydrochloride and pseudoephedrine hydrochloride (Aurohea…

• FDA approval · 2025-04-16
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Montelukast sodium (generic montelukast) submitted by Amneal Pharmaceuticals LLC under ANDA20510…

• FDA approval · 2025-04-08
  FDA Approved: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved the original application for a fixed-dose combination nasal spray of azelastine hydrochloride and fluticasone propionate by Tev…

• FDA approval · 2025-04-03
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for levocetirizine dihydrochloride (Dr. Reddy's Laboratories Inc.), confirming the generic's labelin…

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• FDA approval · 2025-03-13
  FDA Approved: ALLERGY RELIEF — Supplemental Application (Prodose, Inc)

  FDA approved a supplemental application for ALLERGY RELIEF (cetirizine hydrochloride) by Prodose, Inc, authorizing a change under theANDA.

• FDA approval · 2025-02-07
  FDA Approved: IPRATROPIUM BROMIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic ipratropium bromide (ANDA 217912), making a generic version of the drug available for approved C…

• FDA approval · 2025-01-27
  FDA Tentative Approval: AZELASTINE HYDROCHLORIDE — Original Application (Aurohealth LLC)

  FDA issued tentative approval for Aurohealth LLC's azelastine hydrochloride nasal spray (ANDA 216561), a generic product intended for allerg…

• FDA approval · 2024-12-17
  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 · 2024-12-12
  FDA Approved: FLUNISOLIDE — Supplemental Application (Bausch & Lomb Incorporated)

  The FDA approved a supplemental application for Flunisolide by Bausch & Lomb, approving changes related to this product under the ANDA. This…

• FDA approval · 2024-11-21
  FDA Approved: LORATADINE 10 MG — Original Application (TIME CAP LABORATORIES, INC.)

  FDA approved Time Cap Laboratories, Inc.'s loratadine 10 mg tablets via an original ANDA, establishing a generic version of the antihistamin…

• FDA approval · 2024-11-15
  FDA Approved: ZYRTEC ALLERGY — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC ALLERGY (cetirizine hydrochloride) by Kenvue Brands LLC. The approval adds or expands the…

• FDA approval · 2024-11-13
  FDA Approved: CHILDRENS ZYRTEC — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Children's Zyrtec (cetirizine hydrochloride) by Kenvue Brands LLC. The approval pertains to a mo…

• FDA approval · 2024-10-24
  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) from Haleon US Holdings LLC.

• FDA approval · 2024-10-24
  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) from Haleon US Holdings LLC.

• FDA approval · 2024-10-03
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Indoco Remedies Limited)

  FDA approved Indoco Remedies Limited's original application for cetirizine hydrochloride, granting approval for a generic antihistamine prod…

• FDA approval · 2024-09-27
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Montelukast from BluePoint Laboratories under an ANDA, resulting in regulatory approval of t…

• FDA approval · 2024-09-12
  FDA Approved: ZYRTEC-D — Supplemental Application (Kenvue Brands LLC)

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

• FDA approval · 2024-08-15
  FDA Approved: ZYRTEC — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for ZYRTEC (cetirizine hydrochloride) filed by Kenvue Brands LLC.

• FDA approval · 2024-08-14
  FDA Approved: MOMETASONE FUROATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for mometasone furoate from Glenmark Pharmaceuticals Inc., USA under an ANDA.

• FDA approval · 2024-07-11
  FDA Approved: XYZAL ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for XYZAL ALLERGY 24HR (levocetirizine dihydrochloride) filed by Chattem, Inc., related to a sup…

• FDA approval · 2024-06-07
  FDA Approved: RUGBY MOMETASONE FUROATE NASAL — Supplemental Application (Rugby Laboratories)

  FDA approved a supplemental application for Rugby Mometasone Furoate Nasal (mometasone furoate) by Rugby Laboratories. The action pertains t…

• FDA approval · 2024-06-05
  FDA Approved: AZELASTINE HCL — Original Application (Amneal Pharmaceuticals NY LLC)

  ANDA approval for AZELASTINE HCL (azelastine) by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2024-05-29
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Allegiant Health)

  FDA approved the original application for azelastine hydrochloride (generic) submitted by Allegiant Health.

• FDA approval · 2024-05-22
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) from Bayer HealthCare LLC., indicating an approved post-approval c…