Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211675

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RINVOQ (UPADACITINIB)
15MG
Marketing Status: Prescription

Active Ingredient: UPADACITINIB
Proprietary Name: RINVOQ
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211675
Product Number: 001
Approval Date: Aug 16, 2019
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RINVOQ (UPADACITINIB)
30MG
Marketing Status: Prescription

Active Ingredient: UPADACITINIB
Proprietary Name: RINVOQ
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211675
Product Number: 002
Approval Date: Jan 14, 2022
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RINVOQ (UPADACITINIB)
45MG
Marketing Status: Prescription

Active Ingredient: UPADACITINIB
Proprietary Name: RINVOQ
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211675
Product Number: 003
Approval Date: Mar 16, 2022
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information