| NDC Code: |
54123-957 |
| Proprietary Name: |
Zubsolv |
| Suffix: |
|
| Non-Proprietary Name: |
buprenorphine hydrochloride and naloxone hydrochloride |
| Dosage Form: |
TABLET, ORALLY DISINTEGRATING |
| Method: |
SUBLINGUAL |
| Original Marketing Date: |
04-07-2013 |
| Category Name: |
NDA |
| Application Number: |
NDA204242 |
| Labeler: |
OREXO US, INC. |
| Substance Name: |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
| Active Numerator Strength: |
5.7; 1.4 |
| 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 |
