Product NDC: | 0078-0420 |
Proprietary Name: | Enablex |
Non Proprietary Name: | darifenacin |
Active Ingredient(s): | 15 mg/1 & nbsp; darifenacin |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0420 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021513 |
Marketing Category: | NDA |
Start Marketing Date: | 20041222 |
Package NDC: | 0078-0420-15 |
Package Description: | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0420-15) |
NDC Code | 0078-0420-15 |
Proprietary Name | Enablex |
Package Description | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0420-15) |
Product NDC | 0078-0420 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | darifenacin |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20041222 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | DARIFENACIN |
Strength Number | 15 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] |