Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210730

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OLINVYK (OLICERIDINE)
1MG/ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: OLICERIDINE
Proprietary Name: OLINVYK
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1MG/ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210730
Product Number: 001
Approval Date: Oct 30, 2020
Applicant Holder Full Name: TREVENA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLINVYK (OLICERIDINE)
2MG/2ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: OLICERIDINE
Proprietary Name: OLINVYK
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2MG/2ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210730
Product Number: 002
Approval Date: Oct 30, 2020
Applicant Holder Full Name: TREVENA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OLINVYK (OLICERIDINE)
30MG/30ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: OLICERIDINE
Proprietary Name: OLINVYK
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 30MG/30ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210730
Product Number: 003
Approval Date: Oct 30, 2020
Applicant Holder Full Name: TREVENA INC
Marketing Status:  Prescription
Patent and Exclusivity Information