Product NDC: | 0430-0215 |
Proprietary Name: | SARAFEM |
Non Proprietary Name: | fluoxetine hydrochloride |
Active Ingredient(s): | 15 mg/1 & nbsp; fluoxetine hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0430-0215 |
Labeler Name: | Warner Chilcott (US), LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021860 |
Marketing Category: | NDA |
Start Marketing Date: | 20090624 |
Package NDC: | 0430-0215-95 |
Package Description: | 12 TRAY in 1 CASE (0430-0215-95) > 5 CARTON in 1 TRAY > 2 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK |
NDC Code | 0430-0215-95 |
Proprietary Name | SARAFEM |
Package Description | 12 TRAY in 1 CASE (0430-0215-95) > 5 CARTON in 1 TRAY > 2 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK |
Product NDC | 0430-0215 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | fluoxetine hydrochloride |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20090624 |
Marketing Category Name | NDA |
Labeler Name | Warner Chilcott (US), LLC |
Substance Name | FLUOXETINE HYDROCHLORIDE |
Strength Number | 15 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |