Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215206

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QULIPTA (ATOGEPANT)
10MG
Marketing Status: Prescription

Active Ingredient: ATOGEPANT
Proprietary Name: QULIPTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215206
Product Number: 001
Approval Date: Sep 28, 2021
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

QULIPTA (ATOGEPANT)
30MG
Marketing Status: Prescription

Active Ingredient: ATOGEPANT
Proprietary Name: QULIPTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215206
Product Number: 002
Approval Date: Sep 28, 2021
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

QULIPTA (ATOGEPANT)
60MG
Marketing Status: Prescription

Active Ingredient: ATOGEPANT
Proprietary Name: QULIPTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215206
Product Number: 003
Approval Date: Sep 28, 2021
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information