Exercise-induced Bronchoconstriction

• FDA approval · 2012-09-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2012-09-21
  FDA Approved: MONTELUKAST SODIUM — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Montelukast Sodium Original Application under ANDA 202717, granting a generic version of montelukast s…

• FDA approval · 2012-09-18
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for montelukast sodium from Lannett Company, Inc., indicating approval of a supplemental (generic) f…

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

  FDA approves the original ANDA for Montelukast sodium from Dr. Reddy's Laboratories Limited, establishing a generic Montelukast sodium produ…

• 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.

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

  FDA approves the original application for Montelukast Sodium (generic montelukast) manufactured by Lannett Company, Inc. The approval enable…

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

  FDA approved Torrent Pharmaceuticals Limited's original ANDA for montelukast sodium, establishing a generic version of montelukast for the a…

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

  FDA approved a supplemental application for Singulair (montelukast) by Organon LLC, resulting in an update to the product labeling via a sup…

• 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 · 2011-06-10
  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 · 2011-04-27
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC, resulting in updated labeling for the p…

• 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 · 2009-09-08
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for albuterol sulfate by Sandoz Inc, updating an existing approved product.

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

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

• FDA approval · 2008-08-27
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) submitted by GlaxoSmithKline LLC. The approval covers the chang…

• 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 · 2008-04-21
  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 sodium) by Organon LLC, updating the product labeling.

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

  The FDA approved Organon LLC's supplemental application for Singulair (montelukast), leading to updated labeling for the product. This actio…

• 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 · 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…