Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210450

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ORILISSA (ELAGOLIX SODIUM)
EQ 150MG BASE Marketing Status: Prescription

Active Ingredient: ELAGOLIX SODIUM
Proprietary Name: ORILISSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210450
Product Number: 001
Approval Date: Jul 23, 2018
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ORILISSA (ELAGOLIX SODIUM)
EQ 200MG BASE Marketing Status: Prescription

Active Ingredient: ELAGOLIX SODIUM
Proprietary Name: ORILISSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210450
Product Number: 002
Approval Date: Jul 23, 2018
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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