Exercise-induced Bronchoconstriction
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-09-30FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Montelukast Sodium by Amneal Pharmaceuticals LLC. This approval relates to an updated labeling o…
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FDA approval · 2025-07-01FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved a supplemental application for montelukast sodium from Ajanta Pharma USA Inc., updating the approved ANDA product via a supplem…
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FDA approval · 2025-07-01FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
The FDA approved a supplemental application for Montelukast Sodium from Ajanta Pharma USA Inc., under an ANDA.
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FDA approval · 2025-07-01FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved a supplemental application for Montelukast Sodium (generic montelukast) submitted by Ajanta Pharma USA Inc. under ANDA203328.
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FDA approval · 2025-04-16FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Montelukast sodium (generic montelukast) submitted by Amneal Pharmaceuticals LLC under ANDA20510…
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FDA approval · 2025-04-03FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's supplemental application for montelukast sodium (ANDA 201515), enabling the approval of a gen…
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FDA approval · 2024-09-27FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for Montelukast from BluePoint Laboratories under an ANDA, resulting in regulatory approval of t…
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FDA approval · 2024-05-21FDA Approved: ALBUTEROL SULFATE — Original Application (Armstrong Pharmaceuticals, Inc.)
FDA approved the original generic application for albuterol sulfate from Armstrong Pharmaceuticals, Inc. as a generic bronchodilator. It is …
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FDA approval · 2024-05-17FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., authorizing its generic montelukast pr…
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FDA approval · 2023-11-27FDA 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, representing an additional approva…
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FDA approval · 2023-11-27FDA 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, enabling a supplemental …
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FDA approval · 2023-11-21FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approves Accord Healthcare Inc.'s Montelukast Sodium supplemental application for the generic product, enabling its labeling and market …
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FDA approval · 2023-10-02FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)
The FDA approved Westminster Pharmaceuticals, LLC's supplemental application for Montelukast Sodium, a generic product under an ANDA.
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FDA approval · 2023-09-21FDA Approved: MONTELUKAST — Supplemental Application (XLCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for Montelukast from XLCare Pharmaceuticals Inc., authorizing a supplemental action related to a…
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FDA approval · 2023-07-31FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Montelukast Sodium from Macleods Pharmaceuticals Limited, authorizing continued marketing of thi…
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FDA approval · 2023-06-28FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental ANDA for Montelukast Sodium from Unichem Pharmaceuticals (USA), Inc., adding a generic Montelukast Sodium produc…
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FDA approval · 2023-06-26FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approves a supplemental application for montelukast sodium from Lannett Company, Inc., under ANDA200405, authorizing an updated generic …
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FDA approval · 2023-06-23FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.)
FDA approved a supplemental application for ALBUTEROL SULFATE from Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. under an ANDA for a generic p…
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FDA approval · 2023-06-07FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for Montelukast submitted by BluePoint Laboratories.
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FDA approval · 2022-01-19FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Montelukast (generic, Sandoz Inc), updating the product's approval status under the ANDA. Montel…
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FDA approval · 2022-01-19FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Montelukast sodium from Rising Pharma Holdings, Inc., enabling changes to its labeling or indica…
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FDA approval · 2022-01-19FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., updating the labeling under an existing ap…
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FDA approval · 2021-10-28FDA Approved: ALBUTEROL SULFATE — Supplemental Application (American Health Packaging)
FDA approved a supplemental application for albuterol sulfate, a generic inhalation drug, submitted by American Health Packaging.
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FDA approval · 2021-10-15FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Torrent Pharmaceuticals Limited's Montelukast Sodium under ANDA 201515, clearing regulatory appr…
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FDA approval · 2021-10-15FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under an approved ANDA. This action …