| Product NDC: | 68968-9075 |
| Proprietary Name: | BRISDELLE |
| Non Proprietary Name: | paroxetine |
| Active Ingredient(s): | 7.5 mg/1 & nbsp; paroxetine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68968-9075 |
| Labeler Name: | Noven Therapeutics, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA204516 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130628 |
| Package NDC: | 68968-9075-3 |
| Package Description: | 30 CAPSULE in 1 BLISTER PACK (68968-9075-3) |
| NDC Code | 68968-9075-3 |
| Proprietary Name | BRISDELLE |
| Package Description | 30 CAPSULE in 1 BLISTER PACK (68968-9075-3) |
| Product NDC | 68968-9075 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | paroxetine |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20130628 |
| Marketing Category Name | NDA |
| Labeler Name | Noven Therapeutics, LLC |
| Substance Name | PAROXETINE MESYLATE |
| Strength Number | 7.5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |