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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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