| Product NDC: | 16590-922 |
| Proprietary Name: | APLENZIN |
| Non Proprietary Name: | BUPROPION HYDROBROMIDE |
| Active Ingredient(s): | 348 mg/1 & nbsp; BUPROPION HYDROBROMIDE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-922 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022108 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090330 |
| Package NDC: | 16590-922-60 |
| Package Description: | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-922-60) |
| NDC Code | 16590-922-60 |
| Proprietary Name | APLENZIN |
| Package Description | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-922-60) |
| Product NDC | 16590-922 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | BUPROPION HYDROBROMIDE |
| Dosage Form Name | TABLET, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20090330 |
| Marketing Category Name | NDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | BUPROPION HYDROBROMIDE |
| Strength Number | 348 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] |