| NDC Code | 0378-8768-93 |
|---|
| Package Description | 30 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16) |
|---|
| Product NDC | 0378-8768 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Buprenorphine And Naloxone |
|---|
| Non-Proprietary Name | Buprenorphine And Naloxone |
|---|
| Dosage Form | FILM |
|---|
| Usage | BUCCAL; SUBLINGUAL |
|---|
| Start Marketing Date | 20190220 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA207607 |
|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
|---|
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
|---|
| Strength | 12; 3 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
|---|
| DEA Schedule | CIII |
|---|