| Product NDC: | 0228-3155 |
| Proprietary Name: | Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
| Non Proprietary Name: | Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
| Active Ingredient(s): | 8; 2 mg/1; mg/1 & nbsp; Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
| Administration Route(s): | SUBLINGUAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0228-3155 |
| Labeler Name: | Actavis Elizabeth LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA091422 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130304 |
| Package NDC: | 0228-3155-09 |
| Package Description: | 90 TABLET in 1 BOTTLE (0228-3155-09) |
| NDC Code | 0228-3155-09 |
| Proprietary Name | Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
| Package Description | 90 TABLET in 1 BOTTLE (0228-3155-09) |
| Product NDC | 0228-3155 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
| Dosage Form Name | TABLET |
| Route Name | SUBLINGUAL |
| Start Marketing Date | 20130304 |
| Marketing Category Name | ANDA |
| Labeler Name | Actavis Elizabeth LLC |
| Substance Name | BUPRENORPHINE; NALOXONE |
| Strength Number | 8; 2 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |