Product NDC: | 0469-2601 |
Proprietary Name: | Myrbetriq |
Non Proprietary Name: | mirabegron |
Active Ingredient(s): | 25 mg/1 & nbsp; mirabegron |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0469-2601 |
Labeler Name: | Astellas Pharma US, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA202611 |
Marketing Category: | NDA |
Start Marketing Date: | 20120628 |
Package NDC: | 0469-2601-71 |
Package Description: | 10 BLISTER PACK in 1 CARTON (0469-2601-71) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
NDC Code | 0469-2601-71 |
Proprietary Name | Myrbetriq |
Package Description | 10 BLISTER PACK in 1 CARTON (0469-2601-71) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Product NDC | 0469-2601 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | mirabegron |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20120628 |
Marketing Category Name | NDA |
Labeler Name | Astellas Pharma US, Inc. |
Substance Name | MIRABEGRON |
Strength Number | 25 |
Strength Unit | mg/1 |
Pharmaceutical Classes | beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] |