Exercise-induced Bronchoconstriction
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-08-14FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Montelukast sodium from Torrent Pharmaceuticals Limited, formalizing approval of this generic mo…
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FDA approval · 2013-08-06FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for Montelukast Sodium from Dr. Reddy's Laboratories Limited under an ANDA.
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FDA approval · 2013-08-06FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for Montelukast Sodium submitted by Dr. Reddy's Laboratories Limited.
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CLINICAL_TRIALS trial_result · 2013-07-15Clinical Trial Update: Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction [Phase 3]
Phase 3 cross-over study evaluating albuterol HFA for exercise-induced bronchoconstriction was terminated.
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FDA approval · 2013-06-26FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Montelukast by Sandoz Inc., indicating approval of a change to this generic Montelukast product.…
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FDA approval · 2013-04-29FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for Montelukast Sodium (ANDA 202717). This action confirms approval of a supp…
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FDA label_change · 2013-03-21FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast sodium) from Organon LLC, resulting in a labeling change for the product.
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FDA approval · 2013-03-21FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC, resulting in changes to the product lab…
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FDA approval · 2013-02-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
The FDA approved a supplemental application for montelukast sodium submitted by Dr. Reddy's Laboratories Limited. The approval extends the r…
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FDA approval · 2013-02-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental abbreviated new drug application for Montelukast Sodium from Dr. Reddy's Laboratories Limited, expanding generic…
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FDA approval · 2013-01-31FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz Inc. for montelukast, granting approval of changes to the generic montelukast product un…
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FDA approval · 2013-01-31FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Montelukast sodium from Lannett Company, Inc., allowing continued marketing of the generic produ…
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FDA approval · 2012-12-17FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Montelukast Sodium by Accord Healthcare Inc., resulting in an approved modification to the produ…
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FDA approval · 2012-12-13FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for montelukast sodium filed by Rising Pharma Holdings, Inc., indicating approval of a change or add…
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FDA approval · 2012-12-10FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Albuterol Sulfate HFA from Teva, updating or expanding the labeling for the inhalation produ…
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FDA approval · 2012-12-10FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved the supplemental application for Montelukast Sodium from Dr. Reddy's Laboratories Limited, granting approval for this generic m…
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FDA approval · 2012-12-10FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for Montelukast Sodium from Dr.Reddy's Laboratories Limited (ANDA201581).
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FDA approval · 2012-10-18FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC.
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FDA approval · 2012-10-18FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approves a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC.
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FDA approval · 2012-10-16FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for montelukast sodium from Torrent Pharmaceuticals Limited, enabling the generic product to be mark…
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FDA approval · 2012-10-16FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited.
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FDA approval · 2012-09-27FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC.
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FDA approval · 2012-09-21FDA 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…
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FDA approval · 2012-09-18FDA 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…
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CLINICAL_TRIALS trial_result · 2012-08-29Clinical Trial Update: Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fed Condition [Phase 1]
Phase 1 bioequivalence study comparing Montelukast Sodium chewable tablets 4 mg and 5 mg under fed conditions in healthy volunteers has comp…