Allergic Rhinitis

• FDA approval · 2019-01-28
  FDA Approved: AZELASTINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for azelastine hydrochloride from Apotex Corp.

• FDA approval · 2019-01-25
  FDA Approved: ADVIL ALLERGY AND CONGESTION RELIEF — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for ADVIL ALLERGY AND CONGESTION RELIEF, a combination product containing chlorpheniramine maleate, …

• FDA approval · 2019-01-07
  FDA Approved: FLUTICASONE PROPIONATE HFA — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Propionate HFA filed by Prasco Laboratories. The approval updates the product under …

• 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: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application to the Singulair (montelukast) NDA submitted by Organon LLC.

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• 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 · 2018-12-07
  FDA Approved: OLOPATADINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original ANDA for olopatadine hydrochloride, a generic antihistamine indicated for allergic conjunctiv…

• FDA approval · 2018-11-30
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (Armas Pharmaceuticals Inc.)

  FDA approved a supplemental application for diphenhydramine hydrochloride from Armas Pharmaceuticals Inc.

• 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 · 2018-11-16
  FDA Approved: ALLERGY AND SINUS RELIEF — Original Application (Kroger Company)

  FDA approved Kroger's original application for an OTC allergy and sinus relief product containing cetirizine hydrochloride and pseudoephedri…

• FDA approval · 2018-10-17
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Nasacort Allergy 24HR (triamcinolone acetonide) by Chattem, Inc., updating the product labeling …

• FDA approval · 2018-10-03
  FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)

  FDA approved a supplemental application for Claritin (loratadine) from Bayer HealthCare LLC. The action approves changes to the product's la…

• FDA approval · 2018-09-06
  FDA Approved: DYMISTA — Supplemental Application (Viatris Specialty LLC)

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

• 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 · 2018-07-31
  FDA Approved: CLARITIN-D 12 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin-D 12 Hour (loratadine and pseudoephedrine sulfate) to update and expand the product lab…

• FDA approval · 2018-07-31
  FDA Approved: CLARITIN-D 24 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for CLARITIN-D 24 HOUR (loratadine and pseudoephedrine sulfate) from Bayer HealthCare LLC.

• FDA approval · 2018-07-31
  FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's original ANDA for montelukast sodium (generic montelukast).

• FDA approval · 2018-07-30
  FDA Approved: MONTELUKAST — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for montelukast from XLCare Pharmaceuticals Inc. under ANDA 202843.

• FDA approval · 2018-07-26
  FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Montelukast from Sandoz Inc, authorizing the generic montelukast product under an ANDA.

• 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 · 2018-07-23
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., enabling the marketing of the generic prod…

• FDA approval · 2018-07-23
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a generic Montelukast sodium product from Rising Pharma Holdings, Inc.

• FDA approval · 2018-07-23
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Lannett Company, Inc., adding regulatory approval for an additional gene…