FDA.reportPublic FDA data

Application 077416

Type
ANDA
Sponsor
RANBAXY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RISPERIDONERISPERIDONESOLUTION; ORAL1MG/MLNoNo

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 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEAmneal Pharmaceuticals LLCd526af85-ee70-4657-a27e-d451027ffd9e2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RISPERIDONERISPERIDONECoupler LLC5643c32b-310e-4888-e063-6394a90ab62f2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RisperidoneRISPERIDONEATLANTIC BIOLOGICALS CORP.dc8c6638-f487-49df-a265-78caa93e43d82026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee495f20-c668-4d8f-9684-1029a4f232db2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RisperidoneRISPERIDONECoupler LLC55f3ebec-a742-48fc-e063-6394a90a14522026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEANI Pharmaceuticals, Inc.1f47ec91-602f-4fba-8f7e-a5698760b6552026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RISPERIDONERISPERIDONEREMEDYREPACK INC.03d3b52d-3a7d-4595-84c9-332da6ca91712026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RisperidoneRISPERIDONEJanssen Pharmaceutical, Inc.701e1cd8-2868-4d29-85a9-a2212c88165f2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEREMEDYREPACK INC.c84807bd-35d7-4138-8989-42617d69293a2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RISPERIDONERISPERIDONECoupler LLC52bb35ac-1f7d-bfbe-e063-6294a90aa2b92026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RISPERDALRISPERIDONEJanssen Pharmaceuticals, Inc.7e117c7e-02fc-4343-92a1-230061dfc5e02026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RISPERIDONE
Rykindo extended-release microspheresRISPERIDONEShandong Luye Pharmaceutical Co., Ltd.58534c96-96f5-4c2e-a061-92d4506aee912026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RISPERIDONE
RisperidoneRISPERIDONEPD-Rx Pharmaceuticals, Inc.e72a2768-815f-47bf-b2f9-16a93dd106842026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEREMEDYREPACK INC.8a4158fe-37d4-4c97-9c44-1c3489fe2a9f2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEREMEDYREPACK INC.ab1cf6fd-9932-47fc-8736-476cc53a13fa2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
risperidoneRISPERIDONECardinal Health 107, LLC3ce21196-4aa0-469b-8f04-6650b2c48cb52026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: risperidone
generic name: RISPERIDONE
RISPERIDONERISPERIDONEA-S Medication Solutionsa6767972-2d3f-482b-80bd-ac93e28fdd052026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RisperidoneRISPERIDONESolco Healthcare US, LLC43aa2a4f-1123-4f86-800b-9218882f7bcd2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEAmici Pharma, Inc.ca41c144-224a-4d57-88d7-8778e6c69ed22026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.bdb08381-dbfc-442e-8d3c-22d3a0f2f6c52026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31236ORIG2006-08-11