Perennial Allergic Rhinitis

• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for montelukast sodium.

• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, updating regulatory status for the product.

• FDA approval · 2019-11-05
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental ANDA for montelukast sodium from Rising Pharma Holdings, enabling the marketing of a generic montelukast sodium …

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

  FDA approved a supplemental application for Singulair (montelukast) by Organon LLC, marking an additional regulatory action for the product.

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

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

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• FDA approval · 2018-11-21
  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) as a new chewable dosage form, expanding t…

• 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 · 2018-05-18
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for montelukast submitted by BluePoint Laboratories under ANDA 203366. The decision denotes appr…

• FDA approval · 2017-09-18
  FDA Approved: XHANCE — Original Application (OptiNose US, Inc.)

  The FDA approved XHANCE, a new intranasal spray formulation of fluticasone propionate from OptiNose US, Inc., under an original NDA for trea…

• FDA approval · 2017-04-28
  FDA Approved: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE — Original Application (Apotex Corp.)

  FDA approves Apotex's original application for a generic nasal spray combining azelastine hydrochloride with fluticasone propionate for alle…

• FDA approval · 2016-12-13
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2016-08-19
  FDA Approved: FEXOFENADINE HCL — Original Application (Strategic Sourcing Services)

  FDA approves the original application for fexofenadine hydrochloride, a generic antihistamine, submitted by Strategic Sourcing Services.

• FDA approval · 2016-06-23
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Montelukast from BluePoint Laboratories.

• FDA approval · 2016-04-19
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Unichem Pharmaceuticals (USA), Inc., under the ANDA.

• FDA approval · 2016-03-17
  FDA Approved: OMNARIS — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Omnaris (ciclesonide) submitted by Covis Pharma US, Inc. The notice indicates the supplemental a…

• FDA approval · 2016-01-26
  FDA Approved: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for a fixed-dose combination of fexofenadine HCl and pseudoephedrine HCl to treat allergy symptoms w…

• FDA approval · 2016-01-12
  FDA Approved: MONTELUKAST SODIUM — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals, LLC's original application for Montelukast SODIUM, establishing a generic montelukast sodium produ…

• FDA approval · 2015-11-25
  FDA Approved: CLARITIN-D 12 HOUR — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin-D 12 Hour, combining loratadine and pseudoephedrine sulfate. The approval expands the p…

• FDA approval · 2015-10-16
  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 · 2015-10-01
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals Inc)

  FDA approved a supplemental application for levocetirizine dihydrochloride from Marlex Pharmaceuticals Inc, indicating an approved regulator…

• FDA approval · 2015-07-31
  FDA Approved: MONTELUKAST SODIUM — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for montelukast sodium (generic montelukast), authorizing a generic product for t…

• FDA approval · 2015-06-18
  FDA Approved: NASACORT ALLERGY 24HR — Supplemental Application (Chattem, Inc.)

  FDA approved a supplemental application for Nasacort Allergy 24HR (triamcinolone acetonide) from Chattem, Inc.

• FDA approval · 2015-05-22
  FDA Approved: MONTELUKAST SODIUM — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original generic application for montelukast sodium, enabling marketing of a generic montelukast pr…

• FDA approval · 2015-04-16
  FDA Approved: CLARITIN ALLERGY — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Claritin Allergy (loratadine) from Bayer HealthCare LLC.

• FDA approval · 2014-11-19
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Original Application (7-eleven)

  FDA approved a generic version of fexofenadine hydrochloride (ANDA 202039) for allergic rhinitis and chronic urticaria, with 7-eleven as the…