Product NDC: | 0378-7004 |
Proprietary Name: | Paroxetine |
Non Proprietary Name: | paroxetine hydrochloride hemihydrate |
Active Ingredient(s): | 40 mg/1 & nbsp; paroxetine hydrochloride hemihydrate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0378-7004 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078902 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130204 |
Package NDC: | 0378-7004-10 |
Package Description: | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7004-10) |
NDC Code | 0378-7004-10 |
Proprietary Name | Paroxetine |
Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7004-10) |
Product NDC | 0378-7004 |
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 | 40 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |