Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021107

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LOTRONEX (ALOSETRON HYDROCHLORIDE)
EQ 0.5MG BASE Marketing Status: Prescription

Active Ingredient: ALOSETRON HYDROCHLORIDE
Proprietary Name: LOTRONEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021107
Product Number: 002
Approval Date: Dec 23, 2003
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LOTRONEX (ALOSETRON HYDROCHLORIDE)
EQ 1MG BASE Marketing Status: Prescription

Active Ingredient: ALOSETRON HYDROCHLORIDE
Proprietary Name: LOTRONEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021107
Product Number: 001
Approval Date: Feb 9, 2000
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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