Irritable Bowel Syndrome
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-06-25EMA Authorised: Constella (linaclotide) — AbbVie Deutschland GmbH & Co. KG
Constella (linaclotide) has been authorised by the EMA for its indication in irritable bowel syndrome.
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EMA approval · 2026-01-27EMA Authorised: Constella (linaclotide) — AbbVie Deutschland GmbH & Co. KG
The European Medicines Agency authorised Constella (linaclotide) for irritable bowel syndrome, with AbbVie Deutschland GmbH & Co. KG as the …
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FDA approval · 2025-09-15FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Trifluent Pharma, LLC)
FDA approved a supplemental application for dicyclomine hydrochloride submitted by Trifluent Pharma, LLC.
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FDA approval · 2025-06-23FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the Original Application for dicyclomine hydrochloride from Rising Pharma Holdings, Inc., expanding access to this antispasmodi…
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FDA approval · 2024-12-19FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental ANDA for a generic chlordiazepoxide hydrochloride and clidinium bromide combination, manufactured by Ascend …
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FDA approval · 2024-11-15FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved an original generic application for dicyclomine hydrochloride from Rising Pharma Holdings, Inc., making a generic version avail…
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FDA approval · 2024-11-01FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)
FDA approved an original ANDA for dicyclomine hydrochloride by Somerset Therapeutics, LLC, providing a generic version of the antispasmodic …
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FDA approval · 2024-11-01FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)
The FDA approved a generic dicyclomine hydrochloride product under an original ANDA from Somerset Therapeutics, LLC.
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FDA approval · 2024-07-08FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Winder Laboratories LLC)
FDA approved a generic version of the combination drug chlordiazepoxide hydrochloride and clidinium bromide from Winder Laboratories LLC. Th…
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FDA approval · 2024-07-01FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original application for dicyclomine hydrochloride, a generic antispasmodic for irritable bowel syndrom…
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FDA approval · 2024-05-07FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' generic dicyclomine hydrochloride (ANDA217566) for relief of intestinal cramps associated with irritabl…
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FDA approval · 2023-09-14FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Aurobindo Pharma Limited)
FDA approved a generic formulation of chlordiazepoxide hydrochloride and clidinium bromide from Aurobindo Pharma Limited under an Original A…
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FDA approval · 2023-09-08FDA Approved: LOTRONEX — Supplemental Application (Legacy Pharma USA Inc.)
FDA approved a supplemental application for Lotronex (alosetron hydrochloride) from Legacy Pharma USA Inc., indicating an approval-related a…
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FDA approval · 2023-09-08FDA Approved: ALOSETRON HYDROCHLORIDE — Supplemental Application (Eywa Pharma Inc)
FDA approves Eywa Pharma Inc's supplemental application for alosetron hydrochloride (ANDA211621).
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FDA approval · 2023-08-30FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Solco Healthcare US,LLC)
FDA approved the original generic application for dicyclomine hydrochloride from Solco Healthcare US, LLC.
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FDA approval · 2023-08-04FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Bionpharma Inc.)
FDA approved a new generic version of dicyclomine hydrochloride from Bionpharma Inc. (ANDA 217916).
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FDA approval · 2023-07-21FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for a generic combination of chlordiazepoxide hydrochloride and clidinium bromide from Amneal, enabl…
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FDA approval · 2023-06-01FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved the original application for dicyclomine hydrochloride from Upsher-Smith Laboratories, LLC, a generic antispasmodic used to tre…
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FDA approval · 2023-03-24FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Solaris Pharma Corporation)
FDA approved the original application for dicyclomine hydrochloride (generic) from Solaris Pharma Corporation.
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FDA approval · 2023-01-13FDA Approved: LIBRAX — Supplemental Application (Bausch Health US, LLC)
FDA approved a supplemental application for Librax (chlordiazepoxide hydrochloride and clidinium bromide) from Bausch Health US, LLC.
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FDA approval · 2022-12-23FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for the combination drug chlordiazepoxide hydrochloride and clidinium bromide (brand name Librax) ma…
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FDA approval · 2022-12-14FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Trifluent Pharma, LLC)
FDA approved a generic dicyclomine hydrochloride product from Trifluent Pharma, LLC via its Original Application (ANDA 216736).
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FDA approval · 2022-11-28FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Solaris Pharma Corporation)
FDA approved a generic version of dicyclomine hydrochloride under an Original Application (ANDA) for Solaris Pharma Corporation.
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FDA approval · 2021-10-25FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's original application for a generic Librax (chlordiazepoxide hydrochloride and clidinium bromide…
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FDA approval · 2021-04-23FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Novitium Pharma LLC)
The FDA approved Novitium Pharma LLC's original ANDA for dicyclomine hydrochloride, enabling a generic version to enter the market.