Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209819

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SUBLOCADE (BUPRENORPHINE)
100MG/0.5ML (100MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE
Proprietary Name: SUBLOCADE
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 100MG/0.5ML (100MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209819
Product Number: 001
Approval Date: Nov 30, 2017
Applicant Holder Full Name: INDIVIOR INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SUBLOCADE (BUPRENORPHINE)
300MG/1.5ML (200MG/ML)
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE
Proprietary Name: SUBLOCADE
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 300MG/1.5ML (200MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209819
Product Number: 002
Approval Date: Nov 30, 2017
Applicant Holder Full Name: INDIVIOR INC
Marketing Status:  Prescription
Patent and Exclusivity Information