Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202155

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ELIQUIS (APIXABAN)
2.5MG
Marketing Status: Prescription

Active Ingredient: APIXABAN
Proprietary Name: ELIQUIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202155
Product Number: 001
Approval Date: Dec 28, 2012
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Prescription
Patent and Exclusivity Information

ELIQUIS (APIXABAN)
5MG
Marketing Status: Prescription

Active Ingredient: APIXABAN
Proprietary Name: ELIQUIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202155
Product Number: 002
Approval Date: Dec 28, 2012
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Prescription
Patent and Exclusivity Information

ELIQUIS (APIXABAN)
0.5MG
Marketing Status: Prescription

Active Ingredient: APIXABAN
Proprietary Name: ELIQUIS
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202155
Product Number: 003
Approval Date: Apr 17, 2025
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Prescription
Patent and Exclusivity Information