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LOTRONEX (nda021107)- (EQ 1MG BASE,EQ 0.5MG BASE)

ALOSETRON HYDROCHLORIDE LEGACY PHARMA
EQ 1MG BASE,EQ 0.5MG BASE
Yes No
2018-Oct-05 Expired
None None
None No
LOTRONEX is a selective serotonin 5-HT3 antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: • chronic IBS symptoms (generally lasting 6 months or longer), • had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and • not responded adequately to conventional therapy. Severe IBS includes diarrhea and 1 or more of the following: • frequent and severe abdominal pain/discomfort, • frequent bowel urgency or fecal incontinence, • disability or restriction of daily activities due to IBS.
5 0 5
Total Other Developers 3
Drugs with Suitability No
EQ 1MG BASE ** ** Down - 3
EQ 0.5MG BASE ** ** Down - 3
NDA Sales Available Total Generic Sales Available
Yes 5
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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