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: | 16590-922-90 |
Package Description: | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-922-90) |
NDC Code | 16590-922-90 |
Proprietary Name | APLENZIN |
Package Description | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-922-90) |
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] |