Product NDC: | 49909-005 |
Proprietary Name: | Fluoxetine HCl |
Non Proprietary Name: | Fluoxetine HCl |
Active Ingredient(s): | 60 mg/1 & nbsp; Fluoxetine HCl |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 49909-005 |
Labeler Name: | Edgemont Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA202133 |
Marketing Category: | NDA |
Start Marketing Date: | 20111114 |
Package NDC: | 49909-005-30 |
Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE (49909-005-30) |
NDC Code | 49909-005-30 |
Proprietary Name | Fluoxetine HCl |
Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (49909-005-30) |
Product NDC | 49909-005 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Fluoxetine HCl |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20111114 |
Marketing Category Name | NDA |
Labeler Name | Edgemont Pharmaceuticals, LLC |
Substance Name | FLUOXETINE HYDROCHLORIDE |
Strength Number | 60 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |