Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212888

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CABENUVA KIT (CABOTEGRAVIR; RILPIVIRINE)
400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)
Marketing Status: Prescription

Active Ingredient: CABOTEGRAVIR; RILPIVIRINE
Proprietary Name: CABENUVA KIT
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212888
Product Number: 001
Approval Date: Jan 21, 2021
Applicant Holder Full Name: VIIV HEALTHCARE CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CABENUVA KIT (CABOTEGRAVIR; RILPIVIRINE)
600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)
Marketing Status: Prescription

Active Ingredient: CABOTEGRAVIR; RILPIVIRINE
Proprietary Name: CABENUVA KIT
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212888
Product Number: 002
Approval Date: Jan 21, 2021
Applicant Holder Full Name: VIIV HEALTHCARE CO
Marketing Status:  Prescription
Patent and Exclusivity Information