FDA.reportPublic FDA data

Application 217061

Type
ANDA
Sponsor
SAWAI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRABEGRONMIRABEGRONTABLET, EXTENDED RELEASE;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217061-001MIRABEGRONMIRABEGRON50MGTABLET, EXTENDED RELEASE / ORAL2025-05-06

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217061-001MIRABEGRON50MGTABLET, EXTENDED RELEASE / ORAL2025-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217061-001MIRABEGRON50MGTABLET, EXTENDED RELEASE / ORAL2025-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A217061-001MIRABEGRON50MGTABLET, EXTENDED RELEASE / ORAL2025-05-066a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217061-001MIRABEGRON50MGTABLET, EXTENDED RELEASE / ORAL2025-05-06a50c72e98297…

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.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIRABEGRONMIRABEGRONREMEDYREPACK INC.d0054db9-e38a-4786-be2c-996fa5b8f47d2026-05-22Warnings, Adverse reactionsName fallback
brand name: MIRABEGRON
generic name: MIRABEGRON
MirabegronMIRABEGRONAscend Laboratories, LLC1c9022af-4841-4f3f-9737-1c5eef58e86b2026-05-22Warnings, Adverse reactionsName fallback
brand name: Mirabegron
generic name: MIRABEGRON
MirabegronMIRABEGRONREMEDYREPACK INC.b71b939e-8cb1-492c-8311-28f75dc4c6822026-04-27Warnings, Adverse reactionsName fallback
brand name: Mirabegron
generic name: MIRABEGRON
MirabegronMIRABEGRONAmneal Pharmaceuticals NY LLCe597023d-6dcc-4d9e-8ce0-2d28a5d862f32026-03-26Warnings, Adverse reactionsName fallback
brand name: Mirabegron
generic name: MIRABEGRON
MIRABEGRONMIRABEGRONLupin Pharmaceuticals, Inc.d22d3d12-8466-46db-bc19-d13e87c6115c2025-12-24Warnings, Adverse reactionsName fallback
brand name: MIRABEGRON
generic name: MIRABEGRON
MirabegronMIRABEGRONQilu Pharmaceutical Co., Ltd.98247602-29b9-4621-8eeb-519e40b883b92025-10-21Warnings, Adverse reactionsName fallback
brand name: Mirabegron
generic name: MIRABEGRON
MirabegronMIRABEGRONREMEDYREPACK INC.5f7a1758-8691-4e53-96d6-a01626ee81402025-10-02Warnings, Adverse reactionsName fallback
brand name: Mirabegron
generic name: MIRABEGRON
MIRABEGRONMIRABEGRONBryant Ranch Prepack00826723-d25e-498a-b8d4-d17e5c14dda52025-09-26Warnings, Adverse reactionsName fallback
brand name: MIRABEGRON
generic name: MIRABEGRON
MIRABEGRONMIRABEGRONBryant Ranch Prepack1a7337a4-2901-4e65-b666-7623fadb78f22025-09-26Warnings, Adverse reactionsName fallback
brand name: MIRABEGRON
generic name: MIRABEGRON
MIRABEGRONMIRABEGRONBryant Ranch Prepack2965e083-b678-43b9-8e13-2efddc0daad02025-09-26Warnings, Adverse reactionsName fallback
brand name: MIRABEGRON
generic name: MIRABEGRON
MIRABEGRONMIRABEGRONBryant Ranch Prepack3bd73250-2b31-4b22-983b-15119846e6972025-09-26Warnings, Adverse reactionsName fallback
brand name: MIRABEGRON
generic name: MIRABEGRON
MirabegronMIRABEGRONZydus Lifesciences Limited461b2b94-205a-4860-9cb4-d30267ada9df2024-10-09Warnings, Adverse reactionsName fallback
brand name: Mirabegron
generic name: MIRABEGRON
MirabegronMIRABEGRONZydus Pharmaceuticals (USA) Inc.2e40eb74-3b2a-47f7-bf31-fe27484f9bd22024-10-09Warnings, Adverse reactionsName fallback
brand name: Mirabegron
generic name: MIRABEGRON
MyrbetriqMIRABEGRONAstellas Pharma US, Inc.ba9e9e15-e666-4c56-9271-2e24739cfa2d2024-08-01Warnings, Adverse reactionsName fallback
generic name: MIRABEGRON