Diarrhea
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-03-02FDA Approved: IMODIUM MULTI-SYMPTOM RELIEF — Supplemental Application (Kenvue Brands LLC)
The FDA approved a supplemental application to expand the labeling for Imodium Multi-Symptom Relief, a combination product of loperamide hyd…
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FDA approval · 2025-11-17FDA Approved: LOPERAMIDE HYDROCHLORIDE 2MG — Original Application (MARKSANS PHARMA LIMITED)
FDA approved Marksans Pharma Limited's loperamide hydrochloride 2 mg tablets as a generic anti-diarrheal under ANDA 220153.
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FDA approval · 2025-09-19FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for diphenoxylate hydrochloride and atropine sulfate by ANI Pharmaceuticals, expanding/adjusting the…
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FDA approval · 2025-09-19FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Bionpharma Inc.)
FDA approved an oral generic version of loperamide hydrochloride from Bionpharma Inc under an Original ANDA.
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FDA approval · 2024-11-14FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Diphenoxylate hydrochloride and atropine sulfate by Hikma Pharmaceuticals USA Inc., marking a mo…
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FDA approval · 2024-10-11FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Diphenoxylate Hydrochloride and Atropine Sulfate (ANI Pharmaceuticals) under an ANDA.
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FDA approval · 2024-04-03FDA Approved: MYTESI — Supplemental Application (Napo Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Mytesi (crofelemer) from Napo Pharmaceuticals, confirming/expanding its regulatory approval …
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FDA approval · 2023-09-05FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's Original Application for Loperamide hydrochloride, granting approval of a generic anti-diarrheal…
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FDA approval · 2023-03-23FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for loperamide hydrochloride from Zydus Lifesciences Limited. The approval enables a generic version o…
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FDA approval · 2023-01-26FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd.,)
FDA approved Advagen Pharma Ltd.'s original application for loperamide hydrochloride (a generic anti-diarrheal) to treat various forms of di…
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FDA approval · 2022-11-22FDA Approved: LOPERAMIDE HCL AND SIMETHICONE — Supplemental Application (Ohm Laboratories Inc.)
The FDA approved a supplemental application for Loperamide HCl and Simethicone from Ohm Laboratories Inc., updating labeling for the combina…
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FDA approval · 2022-08-29FDA Approved: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE — Original Application (Granules India Ltd)
FDA approved Granules India Ltd's original application for a generic combination product containing loperamide hydrochloride and simethicone…
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FDA approval · 2021-12-13FDA Approved: ANTI DIARRHEAL — Supplemental Application (H E B)
FDA approved a supplemental application for a generic anti-diarrheal drug containing loperamide hydrochloride (LOPERAMIDE HCL).
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FDA approval · 2021-10-06FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Edenbridge Pharmaceuticals LLC.)
FDA approved Edenbridge Pharmaceuticals' original application for a generic version of loperamide hydrochloride.
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FDA approval · 2021-09-10FDA Approved: ANTI-DIARRHEAL/ANTI-GAS CAPLETS — Original Application (YYBA CORP)
FDA approved YYBA CORP's original application for a combination anti-diarrheal and anti-gas caplet containing loperamide hydrochloride 2 mg …
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FDA approval · 2021-08-11FDA Approved: LOPERAMIDE HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved the original application for loperamide hydrochloride from Dr. Reddy's Laboratories Inc., enabling a generic product to treat d…
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FDA approval · 2021-07-09FDA Approved: LOPERAMIDE HYDROCHLORIDE — Supplemental Application (Chain Drug Marketing Association Inc.)
FDA approved a supplemental application for loperamide hydrochloride (generic), submitted by Chain Drug Marketing Association Inc.
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FDA approval · 2021-07-09FDA Approved: ANTI DIARRHEAL ANTI GAS — Supplemental Application (Rite Aid Corporation)
FDA approved a supplemental application for the Rite Aid ANTI DIARRHEAL ANTI GAS product, a combination of loperamide hydrochloride and sime…
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FDA approval · 2021-06-17FDA Approved: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE — Original Application (Camber Consumer Care Inc)
FDA approved the original application for a generic product containing loperamide hydrochloride and simethicone from Camber Consumer Care In…
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FDA approval · 2021-05-27FDA Approved: ANTI-DIARRHEAL/ANTI-GAS MULTI-SYMPTOM RELIEF — Original Application (Wal-Mart Stores, Inc.)
FDA approved Wal-Mart Stores, Inc.'s generic combination product containing loperamide hydrochloride 2 mg and simethicone 125 mg for relief …
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FDA approval · 2021-01-27FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Original Application (Winder Laboratories LLC)
FDA approved the original application for a generic diphenoxylate hydrochloride and atropine sulfate product (ANDA 211362) from Winder Labor…
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FDA approval · 2020-12-14FDA Approved: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE — Original Application (WALMART INC.)
FDA approved Walmart's original application for a generic combination product containing loperamide hydrochloride and simethicone to treat d…
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FDA approval · 2020-10-21FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Original Application (Chartwell RX, LLC)
FDA approved Chartwell RX, LLC's generic diphenoxylate hydrochloride and atropine sulfate for the treatment of diarrhea under an Original AN…
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FDA approval · 2020-10-06FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Original Application (SpecGx LLC)
FDA approved the original application for Diphenoxylate hydrochloride and atropine sulfate (SpecGx LLC). This is a generic antidiarrheal pro…
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FDA approval · 2020-09-09FDA Approved: LOPERAMIDE HYDROCHLORIDE — Supplemental Application (Chain Drug Marketing Association Inc.)
The FDA approved a supplemental application for loperamide hydrochloride under an ANDA, authorizing changes to an existing product submitted…