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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210136

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BRIXADI (BUPRENORPHINE)
8MG/0.16ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BRIXADI
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 8MG/0.16ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210136
Product Number: 001
Approval Date: May 23, 2023
Applicant Holder Full Name: BRAEBURN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRIXADI (BUPRENORPHINE)
16MG/0.32ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BRIXADI
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 16MG/0.32ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210136
Product Number: 002
Approval Date: May 23, 2023
Applicant Holder Full Name: BRAEBURN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRIXADI (BUPRENORPHINE)
24MG/0.48ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BRIXADI
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 24MG/0.48ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210136
Product Number: 003
Approval Date: May 23, 2023
Applicant Holder Full Name: BRAEBURN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRIXADI (BUPRENORPHINE)
32MG/0.64ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BRIXADI
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 32MG/0.64ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210136
Product Number: 004
Approval Date: May 23, 2023
Applicant Holder Full Name: BRAEBURN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRIXADI (BUPRENORPHINE)
64MG/0.18ML (356MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BRIXADI
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 64MG/0.18ML (356MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210136
Product Number: 005
Approval Date: May 23, 2023
Applicant Holder Full Name: BRAEBURN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRIXADI (BUPRENORPHINE)
96MG/0.27ML (356MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BRIXADI
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 96MG/0.27ML (356MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210136
Product Number: 006
Approval Date: May 23, 2023
Applicant Holder Full Name: BRAEBURN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRIXADI (BUPRENORPHINE)
128MG/0.36ML (356MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BRIXADI
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 128MG/0.36ML (356MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210136
Product Number: 007
Approval Date: May 23, 2023
Applicant Holder Full Name: BRAEBURN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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