Exercise-induced Bronchoconstriction
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-07-30FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Aurobindo Pharma Limited to market Montelukast sodium as a generic product.
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FDA approval · 2021-01-29FDA Approved: MONTELUKAST — Supplemental Application (XLCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for Montelukast from XLCare Pharmaceuticals Inc., approving changes to the generic product under…
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FDA approval · 2021-01-25FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare Inc.'s montelukast sodium product under ANDA 202717.
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FDA approval · 2020-11-10FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
The FDA approved a supplemental application for montelukast sodium from Dr. Reddy's Laboratories Limited, under an ANDA.
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FDA approval · 2020-11-10FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for Montelukast Sodium from Dr. Reddy's Laboratories Limited, granting continued approval of a gener…
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FDA approval · 2020-10-20FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, marking approval of a generic montelukast product und…
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FDA approval · 2020-10-20FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved a supplemental application for Montelukast Sodium (ANDA 203432) from Ajanta Pharma USA Inc., granting approval of this generic …
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FDA approval · 2020-10-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Montelukast Sodium by Torrent Pharmaceuticals Limited (ANDA 201515).
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FDA approval · 2020-10-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved Torrent Pharmaceuticals Limited's supplemental application for montelukast sodium, authorizing the regulatory action for th…
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FDA approval · 2020-09-04FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz Inc for montelukast under the ANDA, confirming changes to the generic product's labeling…
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FDA approval · 2020-09-04FDA Approved: MONTELUKAST SODIUM — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' Montelukast Sodium as a generic version of montelukast for the prevention and maintenance treatment of …
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FDA approval · 2020-08-14FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc. This action authorizes changes to the p…
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FDA approval · 2020-02-18FDA Approved: MONTELUKAST SODIUM — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original application for Montelukast Sodium, a generic montelukast product.
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FDA approval · 2019-11-08FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for Montelukast submitted by BluePoint Laboratories. The action pertains to an additional indication…
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FDA approval · 2019-11-08FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s supplemental application for montelukast sodium.
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FDA approval · 2019-11-08FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, enabling the generic montelukast product (ANDA 20…
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FDA approval · 2019-11-08FDA 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.
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FDA approval · 2019-11-07FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's supplemental application for montelukast sodium under ANDA202717, resulting in an updated approved product.…
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FDA approval · 2019-11-05FDA 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 …
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FDA approval · 2019-11-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., enabling a generic product entry. This dec…
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FDA approval · 2019-08-09FDA 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 · 2019-08-09FDA 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.
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FDA approval · 2019-08-09FDA 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 · 2018-12-21FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
The FDA approved a supplemental application to the Singulair (montelukast) NDA submitted by Organon LLC.
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FDA approval · 2018-12-21FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast) submitted by Organon LLC.