Application 202611
- Type
- NDA
- Sponsor
- APGDI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYRBETRIQ | MIRABEGRON | TABLET, EXTENDED RELEASE;ORAL | 25MG | Yes | Yes |
| 002 | MYRBETRIQ | MIRABEGRON | TABLET, EXTENDED RELEASE;ORAL | 50MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0469-2601 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2601 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2601 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2601 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2601 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2601 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2601 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2601 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2602 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2602 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2602 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2602 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2602 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2602 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2602 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-2602 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 55154-8712 | Myrbetriq | mirabegron | Cardinal Health | NDA | Current |
| 55154-8712 | Myrbetriq | mirabegron | Cardinal Health | NDA | Current |
| 55154-8712 | Myrbetriq | mirabegron | Cardinal Health | NDA | Current |
| 55154-8712 | Myrbetriq | mirabegron | Cardinal Health 107, LLC | NDA | Current |
| 55154-8713 | Myrbetriq | mirabegron | Cardinal Health | NDA | Current |
| 55154-8713 | Myrbetriq | mirabegron | Cardinal Health 107, LLC | NDA | Current |
| 55154-8713 | Myrbetriq | mirabegron | Cardinal Health | NDA | Current |
| 55154-8713 | Myrbetriq | mirabegron | Cardinal Health | NDA | Current |
| 70518-2435 | Myrbetriq | mirabegron | REMEDYREPACK INC. | NDA | Current |
| 70518-2435 | Myrbetriq | mirabegron | REMEDYREPACK INC. | NDA | Current |
| 70518-2435 | Myrbetriq | mirabegron | REMEDYREPACK INC. | NDA | Current |
| 70518-2435 | Myrbetriq | mirabegron | REMEDYREPACK INC. | NDA | Current |
| 70518-3158 | Myrbetriq | mirabegron | REMEDYREPACK INC. | NDA | Current |
| 70518-3158 | Myrbetriq | mirabegron | REMEDYREPACK INC. | NDA | Current |
| 70518-3158 | Myrbetriq | mirabegron | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66915 | SUPPL | 2021-03-30 |
| 66894 | SUPPL | 2021-03-26 |
| 54035 | SUPPL | 2018-05-07 |
| 53986 | SUPPL | 2018-05-03 |
| 49193 | SUPPL | 2017-08-02 |
| 49163 | SUPPL | 2017-07-31 |
| 45082 | SUPPL | 2016-08-17 |
| 45129 | SUPPL | 2016-08-16 |
| 32286 | SUPPL | 2015-11-04 |
| 19363 | SUPPL | 2015-11-04 |
| 19364 | SUPPL | 2015-08-11 |
| 10086 | SUPPL | 2015-08-11 |
| 22893 | ORIG | 2012-08-10 |
| 40205 | ORIG | 2012-06-28 |
| 32285 | ORIG | 2012-06-28 |