Product NDC: | 0430-0170 |
Proprietary Name: | Enablex |
Non Proprietary Name: | darifenacin |
Active Ingredient(s): | 7.5 mg/1 & nbsp; darifenacin |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0430-0170 |
Labeler Name: | Warner Chilcott (US), LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021513 |
Marketing Category: | NDA |
Start Marketing Date: | 20041222 |
Package NDC: | 0430-0170-95 |
Package Description: | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0430-0170-95) |
NDC Code | 0430-0170-95 |
Proprietary Name | Enablex |
Package Description | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0430-0170-95) |
Product NDC | 0430-0170 |
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 | Warner Chilcott (US), LLC |
Substance Name | DARIFENACIN HYDROBROMIDE |
Strength Number | 7.5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] |