Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207924

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OLUMIANT (BARICITINIB)
1MG
Marketing Status: Prescription

Active Ingredient: BARICITINIB
Proprietary Name: OLUMIANT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207924
Product Number: 002
Approval Date: Oct 8, 2019
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

OLUMIANT (BARICITINIB)
2MG
Marketing Status: Prescription

Active Ingredient: BARICITINIB
Proprietary Name: OLUMIANT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207924
Product Number: 001
Approval Date: May 31, 2018
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

OLUMIANT (BARICITINIB)
4MG
Marketing Status: Prescription

Active Ingredient: BARICITINIB
Proprietary Name: OLUMIANT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207924
Product Number: 003
Approval Date: May 10, 2022
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information