FDA.reportPublic FDA data

Application 216757

Type
ANDA
Sponsor
SUNSHINE LAKE PHARMA CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002MIRABEGRONMIRABEGRONTABLET, EXTENDED RELEASE25MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 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