| NDC Code | 0469-2601-90 |
|---|
| Package Description | 1 BOTTLE in 1 CARTON (0469-2601-90) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
|---|
| Product NDC | 0469-2601 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Myrbetriq |
|---|
| Non-Proprietary Name | Mirabegron |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20120628 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA202611 |
|---|
| Manufacturer | Astellas Pharma US, Inc. |
|---|
| Substance Name | MIRABEGRON |
|---|
| Strength | 25 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC] |
|---|