Irritable Bowel Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-02-05FDA 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 · 2020-10-20FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Chartwell RX, LLC)
FDA approves the fixed-dose combination of chlordiazepoxide hydrochloride and clidinium bromide under an original application for Chartwell …
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FDA approval · 2020-07-29FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Misemer Pharmaceuticals, Inc)
FDA approved an original ANDA for chlordiazepoxide hydrochloride and clidinium bromide, a generic combination product used for GI spasms and…
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FDA approval · 2020-07-07FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Sunrise Pharmaceutical, Inc.)
FDA approves Sunrise Pharmaceutical's original application for a generic fixed-dose combination of chlordiazepoxide hydrochloride and clidin…
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FDA approval · 2020-05-22FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA's generic dicyclomine hydrochloride as an original ANDA product (ANDA212286).
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FDA approval · 2019-04-03FDA Approved: LOTRONEX — Supplemental Application (Legacy Pharma USA Inc.)
FDA approved a supplemental application for Lotronex (alosetron hydrochloride) by Legacy Pharma USA Inc., approving a supplemental submissio…
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FDA approval · 2019-01-25FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)
The FDA approved the original application for dicyclomine hydrochloride from Fresenius Kabi USA, LLC. This approval makes a generic version …
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FDA approval · 2018-11-02FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved Slate Run Pharmaceuticals' generic dicyclomine hydrochloride under ANDA207076; the drug is an antispasmodic indicated for irrit…
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FDA approval · 2018-07-02FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Fosun Pharma USA Inc.)
FDA approved a generic version of dicyclomine hydrochloride under ANDA210979 for irritable bowel syndrome.
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FDA approval · 2017-12-27FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for dicyclomine hydrochloride from Endo USA, Inc. The action updates the product's labeling/approval…
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FDA approval · 2016-01-07FDA Approved: LOTRONEX — Supplemental Application (Legacy Pharma USA Inc.)
FDA approved a supplemental application for Lotronex (alosetron hydrochloride) from Legacy Pharma USA Inc.
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FDA approval · 2015-07-24FDA Approved: LOTRONEX — Supplemental Application (Legacy Pharma USA Inc.)
FDA approved a supplemental application for Lotronex (alosetron hydrochloride) submitted by Legacy Pharma USA Inc. The snippet does not spec…
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FDA approval · 2015-05-27FDA Approved: VIBERZI — Original Application (Allergan, Inc.)
The FDA approved VIBERZI (eluxadoline) from Allergan as the original approval for treating irritable bowel syndrome. This marks the introduc…
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FDA approval · 2015-03-05FDA Approved: DICYCLOMINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for dicylomine hydrochloride (Dicyclomine) by Hikma Pharmaceuticals USA Inc., reflecting an amendmen…
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FDA approval · 2014-05-08FDA Approved: LOTRONEX — Supplemental Application (Legacy Pharma USA Inc.)
The FDA approved a supplemental application for Lotronex (alosetron hydrochloride) submitted by Legacy Pharma USA Inc.
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FDA approval · 2013-11-27FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for dicyclomine hydrochloride (Actavis Pharma, Inc.), updating an existing approved product.
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FDA approval · 2013-11-27FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for dicyclomine hydrochloride submitted by Actavis Pharma, Inc., updating the approval for this gene…
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FDA approval · 2013-04-30FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for dicyclomine hydrochloride (generic) filed by Lannett Company, Inc., approving the supplement…
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FDA approval · 2013-04-30FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for dicyclomine hydrochloride from Aurobindo Pharma Limited, allowing a generic version to be market…
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FDA approval · 2013-04-30FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)
The FDA approved Lannett's supplemental application to market a generic dicyclomine hydrochloride product. Dicyclomine hydrochloride is used…
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FDA approval · 2013-04-19FDA Approved: LOTRONEX — Supplemental Application (Legacy Pharma USA Inc.)
FDA supplemental application approval for Lotronex (alosetron hydrochloride) submitted by Legacy Pharma USA Inc.
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FDA approval · 2012-12-31FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for dicyclomine hydrochloride by Actavis Pharma, Inc., supporting continued availability under the a…
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FDA approval · 2012-12-28FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for dicyclomine hydrochloride from Aurobindo Pharma Limited, enabling expanded approval of the g…
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EMA approval · 2012-09-21European Medicines Agency recommends authorisation of first medicine specifically for irritable bowel syndrome
The EMA recommends authorisation of the first medicine specifically for irritable bowel syndrome, marking a milestone for IBS treatment opti…
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FDA approval · 2011-09-30FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for dicyclomine hydrochloride generic product by Lannett Company, Inc., granting continued approval …