Suboxone - buprenorphine hydrochloride, naloxone hydrochloride
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Field |
Value |
NDC Code: |
12496-1208 |
Proprietary Name: |
Suboxone |
Suffix: |
|
Non-Proprietary Name: |
buprenorphine hydrochloride, naloxone hydrochloride |
Dosage Form: |
FILM, SOLUBLE |
Method: |
SUBLINGUAL |
Original Marketing Date: |
13-09-2010 |
Category Name: |
NDA |
Application Number: |
NDA022410 |
Labeler: |
RECKITT BENCKISER PHARMACEUTICALS INC |
Substance Name: |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
Active Numerator Strength: |
8; 2 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
DEA Schedule: |
CIII |