Application 217061
- Type
- ANDA
- Sponsor
- SAWAI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRABEGRON | MIRABEGRON | TABLET, EXTENDED RELEASE;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217061-001 | MIRABEGRON | MIRABEGRON | 50MG | TABLET, EXTENDED RELEASE / ORAL | 2025-05-06 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217061-001 | MIRABEGRON | 50MG | TABLET, EXTENDED RELEASE / ORAL | 2025-05-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217061-001 | MIRABEGRON | 50MG | TABLET, EXTENDED RELEASE / ORAL | 2025-05-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217061-001 | MIRABEGRON | 50MG | TABLET, EXTENDED RELEASE / ORAL | 2025-05-06 | 6a471c1ec25d… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217061-001 | MIRABEGRON | 50MG | TABLET, EXTENDED RELEASE / ORAL | 2025-05-06 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MIRABEGRON | MIRABEGRON | REMEDYREPACK INC. | d0054db9-e38a-4786-be2c-996fa5b8f47d | 2026-05-22 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| Mirabegron | MIRABEGRON | Ascend Laboratories, LLC | 1c9022af-4841-4f3f-9737-1c5eef58e86b | 2026-05-22 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Mirabegron | MIRABEGRON | REMEDYREPACK INC. | b71b939e-8cb1-492c-8311-28f75dc4c682 | 2026-04-27 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Mirabegron | MIRABEGRON | Amneal Pharmaceuticals NY LLC | e597023d-6dcc-4d9e-8ce0-2d28a5d862f3 | 2026-03-26 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Lupin Pharmaceuticals, Inc. | d22d3d12-8466-46db-bc19-d13e87c6115c | 2025-12-24 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| Mirabegron | MIRABEGRON | Qilu Pharmaceutical Co., Ltd. | 98247602-29b9-4621-8eeb-519e40b883b9 | 2025-10-21 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Mirabegron | MIRABEGRON | REMEDYREPACK INC. | 5f7a1758-8691-4e53-96d6-a01626ee8140 | 2025-10-02 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 00826723-d25e-498a-b8d4-d17e5c14dda5 | 2025-09-26 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 1a7337a4-2901-4e65-b666-7623fadb78f2 | 2025-09-26 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 2965e083-b678-43b9-8e13-2efddc0daad0 | 2025-09-26 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| MIRABEGRON | MIRABEGRON | Bryant Ranch Prepack | 3bd73250-2b31-4b22-983b-15119846e697 | 2025-09-26 | Warnings, Adverse reactions | MIRABEGRON MIRABEGRON |
| Mirabegron | MIRABEGRON | Zydus Lifesciences Limited | 461b2b94-205a-4860-9cb4-d30267ada9df | 2024-10-09 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Mirabegron | MIRABEGRON | Zydus Pharmaceuticals (USA) Inc. | 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2 | 2024-10-09 | Warnings, Adverse reactions | Mirabegron MIRABEGRON |
| Myrbetriq | MIRABEGRON | Astellas Pharma US, Inc. | ba9e9e15-e666-4c56-9271-2e24739cfa2d | 2024-08-01 | Warnings, Adverse reactions | MIRABEGRON |