| Product NDC: | 0378-7001 |
| Proprietary Name: | Paroxetine |
| Non Proprietary Name: | paroxetine hydrochloride hemihydrate |
| Active Ingredient(s): | 10 mg/1 & nbsp; paroxetine hydrochloride hemihydrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0378-7001 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078902 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130204 |
| Package NDC: | 0378-7001-01 |
| Package Description: | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-01) |
| NDC Code | 0378-7001-01 |
| Proprietary Name | Paroxetine |
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-01) |
| Product NDC | 0378-7001 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | paroxetine hydrochloride hemihydrate |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20130204 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | PAROXETINE HYDROCHLORIDE HEMIHYDRATE |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |