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Generated: November 15, 2018

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Details for New Drug Application (NDA): 209819

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NDA 209819 describes SUBLOCADE, which is a drug marketed by Indivior Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the SUBLOCADE profile page.

The generic ingredient in SUBLOCADE is buprenorphine. There are twenty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 209819
Tradename:SUBLOCADE
Applicant:Indivior Inc
Ingredient:buprenorphine
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 209819
Mechanism of ActionPartial Opioid Agonists
Medical Subject Heading (MeSH) Categories for 209819
Suppliers and Packaging for NDA: 209819
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819 NDA Indivior Inc. 12496-0100 12496-0100-1 1 POUCH in 1 CARTON (12496-0100-1) > 1 SYRINGE in 1 POUCH (12496-0100-2) > 1 SOLUTION in 1 SYRINGE (12496-0100-5)
SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819 NDA Indivior Inc. 12496-0300 12496-0300-1 1 POUCH in 1 CARTON (12496-0300-1) > 1 SYRINGE in 1 POUCH (12496-0300-2) > 1 SOLUTION in 1 SYRINGE (12496-0300-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, EXTENDED RELEASE;SUBCUTANEOUSStrength100MG/0.5ML (100MG/0.5ML)
Approval Date:Nov 30, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 30, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Jan 6, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
Patent:➤ Try a Free TrialPatent Expiration:Jan 6, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH

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