Seasonal Allergic Rhinitis

• FDA approval · 2012-08-06
  FDA Approved: MONTELUKAST SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved the original application for Montelukast Sodium from Dr. Reddy's Laboratories Limited (ANDA 201581). This approval makes Montel…

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic montelukast sodium product from Rising Pharma Holdings, Inc. under ANDA 202468.

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved the original application for Montelukast Sodium (generic) from Rising Pharma Holdings, expanding access to montelukast prod…

• FDA approval · 2012-08-03
  FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's Montelukast Sodium as an original generic application (ANDA 201515).

• FDA approval · 2012-02-03
  FDA Approved: ALLEGRA-D ALLERGY AND CONGESTION — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for Allegra-D Allergy and Congestion (fexofenadine hydrochloride and pseudoephedrine hydrochlori…

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• FDA approval · 2011-12-16
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC. The approval updates the product labeli…

• FDA approval · 2011-09-23
  FDA Approved: FEXOFENADINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for fexofenadine hydrochloride from Dr. Reddy's Laboratories Limited, enabling the generic produ…

• FDA approval · 2011-06-10
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved Organon LLC's supplemental application for Singulair (montelukast sodium), granting approval of the requested supplemental acti…

• FDA approval · 2011-04-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2011-04-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2010-08-10
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) filed by Organon LLC, resulting in labeling changes to reflect the suppl…

• FDA approval · 2010-03-17
  FDA Approved: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' original application for a generic fixed-dose combination of fexofenadine HCl and pseudoephedrine HCl…

• FDA approval · 2010-01-25
  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) from Bayer HealthCare LLC.

• FDA approval · 2009-08-19
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a Supplemental Application for Singulair (montelukast sodium) submitted by Organon LLC. This action typically results in labeli…

• FDA approval · 2009-04-30
  FDA Approved: AZELASTINE HYDROCHLORIDE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original application for azelastine hydrochloride, a generic antihistamine product.

• FDA approval · 2008-06-20
  FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's cetirizine hydrochloride under an original generic application, enabling a generic cetirizine hydrochlorid…

• FDA approval · 2008-04-21
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2008-03-07
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) by Organon LLC. The action updates labeling under NDA020829.

• FDA approval · 2007-11-21
  FDA Approved: OMNARIS — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Omnaris (ciclesonide) submitted by Covis Pharma US, Inc., authorizing an update to the produ…

• FDA approval · 2007-09-19
  FDA Approved: GOOD NEIGHBOR PHARMACY CHILDRENS LORATADINE — Supplemental Application (AmerisourceBergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Children's Loratadine (loratadine) sponsored by AmerisourceBergen.

• FDA approval · 2007-07-26
  FDA Approved: CHILDRENS ALLEGRA ALLERGY — Original Application (Chattem, Inc.)

  FDA approved the original application for CHILDRENS ALLEGRA ALLERGY (fexofenadine hydrochloride) by Chattem, Inc., establishing its pediatri…

• FDA approval · 2007-07-19
  FDA Approved: CLARINEX-D 12 HOUR — Supplemental Application (Organon LLC)

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

• FDA approval · 2007-04-27
  FDA Approved: FLONASE SENSIMIST ALLERGY RELIEF — Original Application (Haleon US Holdings LLC)

  FDA approved FLONASE SENSIMIST ALLERGY RELIEF (fluticasone furoate) under an original NDA from Haleon US Holdings LLC for relief of symptoms…

• FDA approval · 2007-04-13
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2006-05-19
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) by Organon LLC, resulting in labeling modifications related to its indic…