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SUBLOCADE (nda209819)- (100MG/0.5ML (100MG/0.5ML),300MG/1.5ML (200MG/ML))

BUPRENORPHINE INDIVIOR
100MG/0.5ML (100MG/0.5ML),300MG/1.5ML (200MG/ML)
No Yes
2035-Nov-06 Expired
None 2020-Nov-30
None No
SUBLOCADE contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine containing product, followed by dose adjustment for a minimum of 7 days. SUBLOCADE should be used as part of a complete treatment program that includes counseling and psychosocial support.
0 0 0
Total Other Developers 2
Drugs with Suitability No
100MG/0.5ML (100MG/0.5ML) ** ** - - -
300MG/1.5ML (200MG/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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