Exercise-induced Bronchoconstriction
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-06-02FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for Montelukast Sodium from Lannett Company, Inc., supporting a generic montelukast product.
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FDA approval · 2016-04-19FDA 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.
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FDA approval · 2016-03-01FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's supplemental application for Montelukast Sodium (montelukast) under an ANDA.
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FDA approval · 2016-01-12FDA 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…
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FDA approval · 2016-01-04FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited. The entry indicates a supplemental appr…
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FDA approval · 2015-10-08FDA Approved: MONTELUKAST SODIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved Unichem Pharmaceuticals (USA), Inc.'s Montelukast Sodium generic under Original Application (ANDA204290), authorizing its marke…
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FDA approval · 2015-09-25FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Montelukast Sodium submitted by Macleods Pharmaceuticals Limited.
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FDA approval · 2015-07-31FDA Approved: MONTELUKAST SODIUM — Original Application (Ajanta Pharma USA Inc.)
FDA approved Montelukast Sodium as an original application generic product for Ajanta Pharma USA Inc.
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FDA approval · 2015-07-31FDA Approved: MONTELUKAST SODIUM — Original Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA Inc.'s montelukast sodium generic under an Original Application (ANDA 203432). The product is approved for th…
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FDA approval · 2015-07-31FDA 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…
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FDA approval · 2015-05-22FDA 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…
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CLINICAL_TRIALS trial_result · 2015-05-19Clinical Trial Update: Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB) [Phase 3]
A Phase 3 trial assessing the efficacy of SPIROMAX albuterol for exercise-induced bronchoconstriction in adults and adolescents has complete…
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FDA approval · 2015-05-04FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)
FDA approved a Supplemental Application for montelukast submitted by Sandoz Inc.
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FDA approval · 2015-03-16FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for Montelukast Sodium.
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FDA approval · 2015-03-12FDA Approved: MONTELUKAST SODIUM — Original Application (Macleods Pharmaceuticals Limited)
The FDA approved Montelukast Sodium from Macleods Pharmaceuticals Limited under an Original Application (ANDA 203582).
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FDA label_change · 2014-11-26FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a labeling supplemental application for Singulair (montelukast) submitted by Organon LLC.
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FDA approval · 2014-11-26FDA 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 · 2014-09-11FDA Approved: MONTELUKAST — Original Application (BluePoint Laboratories)
FDA approved Montelukast from BluePoint Laboratories under an Original Application (ANDA), granting generic montelukast access for approved …
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FDA approval · 2014-09-10FDA Approved: MONTELUKAST — Original Application (XLCare Pharmaceuticals Inc.)
FDA approves the original abbreviated new drug application for Montelukast (generic) submitted by XLCare Pharmaceuticals Inc.
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FDA approval · 2014-04-07FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under an ANDA.
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FDA approval · 2014-04-07FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for montelukast sodium from Torrent Pharmaceuticals Limited, granting generic approval under ANDA 20…
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FDA approval · 2014-01-21FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Ventolin HFA (albuterol sulfate) from GlaxoSmithKline, expanding the labeling per the supplement…
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FDA approval · 2013-12-30FDA 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 · 2013-08-23FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
The FDA approved a supplemental application for Montelukast Sodium submitted by Accord Healthcare Inc. The snippet does not specify the exac…
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FDA approval · 2013-08-20FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental ANDA from Lannett Company to market a generic montelukast sodium product. Montelukast is used in the managem…