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SUBLOCADE

NDA · New Drug Application · Sponsor: INDIVIOR · Approved 2017-11-30

Drug application

FDA Application #

NDA209819

Application type

New Drug Application

Brand name

SUBLOCADE

Generic name

BUPRENORPHINE

Active ingredients

BUPRENORPHINE

Dosage form

SOLUTION, EXTENDED RELEASE

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

INDIVIOR

Manufacturer

Indivior Inc.

First approval

2017-11-30

Source

Authoritative

Drugs@FDA application overview

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