FDA.reportPublic FDA data

Application 021440

Type
NDA
Sponsor
FOREST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEXAPROESCITALOPRAM OXALATETABLET; ORALEQ 5MG BASENoNo
002LEXAPROESCITALOPRAM OXALATETABLET; ORALEQ 10MG BASENoNo
003LEXAPROESCITALOPRAM OXALATETABLET; ORALEQ 20MG BASENoNo

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals LLC8704d062-fa91-4224-9dec-41664d20ee6b2024-09-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutions76993020-6715-4090-847e-0fdcc5328f312024-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutionsc980262b-31f0-46df-902d-e593e1557fef2024-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATENorthStar RxLLC81840aec-96fd-4af2-bd10-3f38d068f39a2024-07-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEMacleods Pharmaceuticals Limited24b43cb4-1a26-44a2-b1d8-a40239eb5c7c2024-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutionsb85ef018-0217-4ddf-885d-206acc0a5f842024-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEAdvanced Rx Pharmacy of Tennessee, LLC138f8703-2f13-6d07-e063-6394a90a44132024-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
LexaproESCITALOPRAMAllergan, Inc.13bb8267-1cab-43e5-acae-55a4d957630a2023-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lexapro
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsac9ede0c-7912-4e7d-83b3-964feee612152023-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutions10b25a10-c5e7-479b-a9f5-7eeafd8023232023-04-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEProficient Rx LP8201a719-7837-45fb-b991-4fcdbf006d242023-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEProficient Rx LP52df055d-b1c8-4de2-8545-ef08b5bf9c392022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEProficient Rx LP2d0b4839-e4d1-4e0e-9dc0-ba821f2664722022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEProficient Rx LPe773030f-d07d-4bb8-9dc9-6f649688346d2020-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44123ORIG2005-07-29
36933ORIG2004-06-08
21659ORIG2004-04-12
27786ORIG2002-08-29