FDA.reportPublic FDA data

Application 022042

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVISTARALOXIFENE HYDROCHLORIDETABLET; ORAL60MGNoNo

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 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEAmneal Pharmaceuticals LLC3798c70b-a4b0-4811-9788-e4c9cff47ebe2026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
EvistaRALOXIFENE HYDROCHLORIDEEli Lilly and Companyfcaaa6dc-74e8-4fb8-800c-5574bf0f8de92026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Evista
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEAvPAK6f7eb934-aa60-51e1-e053-2a91aa0a39142026-01-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEA-S Medication Solutions804e873e-f48b-4c25-ad7b-41d44f61bdde2025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEMajor Pharmaceuticalse2967d3c-238c-40cf-b3d8-89482a5029282025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepack7e4bfee5-fefc-4115-9bdb-222eccefca832024-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAc05521f8-95d2-44b8-8433-eba539c0f84c2024-05-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepack5a22ae27-1c55-487b-8e93-8ef1cec870652024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDENorthStar Rx LLC0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf2024-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEAurobindo Pharma Limitede8b6cbe0-c1f4-4678-b852-f629a7f6a1b52024-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEA-S Medication Solutions22a951ee-2ffc-4c60-b681-0f80285153e12023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepack3568ed3c-6afd-4872-a861-93a7873bec9c2023-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepackad3ef791-ac90-4f66-8da6-95b31e4c3eb62023-03-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEScieGen Pharmaceuticals Inc8152e68b-61a8-4897-8e03-900135b1dbd52023-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEDr.Reddys Laboratories Inc8f24455c-34dc-4e07-bcd3-24326b9cc3772022-12-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDECadila Pharmaceuticals Limiteda46bcc4f-f63d-4200-836d-a653a3c616db2022-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEModavar Pharmaceuticals LLCf0db29f5-28da-4165-94f8-24727b6b71e52022-01-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e6be5b1d-757d-4bab-ad6a-c421960a104d2021-08-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEExelan Pharmaceuticals, Inc.2b94ecf5-d870-4132-b455-d5ee5c9dce562020-09-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochlorideRALOXIFENE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC6fd63a06-5bc5-4c50-9b85-b09c89100b802018-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RALOXIFENE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43814ORIG2009-11-18
42398ORIG2009-03-12
6744ORIG2007-09-25
16817ORIG2007-09-14