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Alosetron hydrochloride - Generic Drug Details

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Alosetron hydrochloride is the generic ingredient in two branded drugs marketed by Sebela Ireland Ltd and Roxane, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for alosetron hydrochloride. Four suppliers are listed for this compound.

Summary for Generic Name: alosetron hydrochloride

Tradenames:2
Patents:0
Applicants:2
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packaging: see list4
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: alosetron hydrochloride

Clinical Trials for: alosetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-001Feb 9, 2000RXYes<disabled><disabled>
Roxane
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride
TABLET;ORAL200652-001May 4, 2015RXNo<disabled><disabled>
Roxane
ALOSETRON HYDROCHLORIDE
alosetron hydrochloride
TABLET;ORAL200652-002May 4, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: alosetron hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-001Feb 9, 20005,360,800<disabled>
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-002Dec 23, 20035,360,800<disabled>
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