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 2 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
RisperidoneRISPERIDONETorrent Pharmaceuticals Limiteda6347895-5f16-43b4-92a0-b9904ac819372026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
risperidoneRISPERIDONELupin Pharmaceuticals, Inc.b462e48c-ef1d-4591-8fca-6b5829d8ed902026-02-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: risperidone
generic name: RISPERIDONE
RISPERIDONERISPERIDONEREMEDYREPACK INC.2776a647-678d-465c-9db3-4a9459ce779e2026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RISPERIDONERISPERIDONEREMEDYREPACK INC.5d9519af-5a5e-47ce-8a0f-9b9cfac00e192026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee7d6779-7421-4761-99d2-ccbfde9385a82026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RISPERIDONERISPERIDONEREMEDYREPACK INC.101b2d4d-4740-4225-94bc-aecc05d82c6b2026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RisperidoneRISPERIDONEPar Health USA, LLCd0ef6df3-67e5-47b1-bcf7-f67aa030caca2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
risperidoneRISPERIDONEMajor Pharmaceuticalsd5abd75f-7f4a-4a7d-b849-82fce88f5ff72026-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEWestminster Pharmaceuticals, LLC07d43bf6-a695-453a-a5c7-9581effe585c2025-12-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEGolden State Medical Supply, Inc.448467a3-44ef-c87b-e063-6294a90a5ec92025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEAmerican Health Packagingf11dae15-b057-4258-9229-3819d0c980fe2025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RISPERDAL CONSTARISPERIDONEJanssen Pharmaceuticals, Inc.bb34ee82-d2c2-43b8-ba21-2825c09546912025-11-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RISPERIDONE
RisperidoneRISPERIDONEJubilant Cadista Pharmacuticals Inc.739dcf8a-ed73-5eb0-899b-7e51cb73c3352025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RISPERIDONERISPERIDONEAjanta Pharma USA Inc.095630bd-a77e-434e-94ee-f13da445d8f22025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RISPERIDONE
generic name: RISPERIDONE
RisperidoneRISPERIDONEAvKARE3d4c51e2-b09b-9fd0-e063-6294a90ae6992025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEBryant Ranch Prepack4604052d-dbda-4535-b7b8-1bd72a129aca2025-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONENuCare Pharmaceuticals, Inc.390904c2-fcfa-466e-e063-6394a90a03af2025-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE
RisperidoneRISPERIDONEJubilant Cadista Pharmacuticals Inc.39d41b28-93eb-446b-9652-7432858ccbab2025-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Risperidone
generic name: RISPERIDONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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