| NDC Code: |
0406-1923 |
| Proprietary Name: |
Buprenorphine HCl and Naloxone HCl |
| Suffix: |
|
| Non-Proprietary Name: |
Buprenorphine and Naloxone |
| Dosage Form: |
TABLET |
| Method: |
SUBLINGUAL |
| Original Marketing Date: |
22-02-2013 |
| Category Name: |
ANDA |
| Application Number: |
ANDA203136 |
| Labeler: |
MALLINCKRODT, INC. |
| Substance Name: |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
| Active Numerator Strength: |
2; .5 |
| 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 |
