| NDC Code | 59385-014-30 |
|---|
| Package Description | 30 POUCH in 1 BOX (59385-014-30) > 1 FILM in 1 POUCH (59385-014-01) |
|---|
| Product NDC | 59385-014 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Bunavail |
|---|
| Non-Proprietary Name | Buprenorphine And Naloxone |
|---|
| Dosage Form | FILM |
|---|
| Usage | BUCCAL |
|---|
| Start Marketing Date | 20140930 |
|---|
| End Marketing Date | 20211031 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA205637 |
|---|
| Manufacturer | BioDelivery Sciences International, Inc. |
|---|
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
|---|
| Strength | 4.2; .7 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
|---|
| DEA Schedule | CIII |
|---|