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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210166

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MOTEGRITY (PRUCALOPRIDE SUCCINATE)
EQ 1MG BASE
Marketing Status: Prescription
Active Ingredient: PRUCALOPRIDE SUCCINATE
Proprietary Name: MOTEGRITY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210166
Product Number: 001
Approval Date: Dec 14, 2018
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MOTEGRITY (PRUCALOPRIDE SUCCINATE)
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: PRUCALOPRIDE SUCCINATE
Proprietary Name: MOTEGRITY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210166
Product Number: 002
Approval Date: Dec 14, 2018
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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