Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211765

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UBRELVY (UBROGEPANT)
50MG
Marketing Status: Prescription

Active Ingredient: UBROGEPANT
Proprietary Name: UBRELVY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211765
Product Number: 001
Approval Date: Dec 23, 2019
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UBRELVY (UBROGEPANT)
100MG
Marketing Status: Prescription

Active Ingredient: UBROGEPANT
Proprietary Name: UBRELVY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211765
Product Number: 002
Approval Date: Dec 23, 2019
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information