FDA.reportPublic FDA data

Application 078467

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET; ORAL5MGNoNo
002ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET; ORAL10MGNoNo
003ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET; ORAL20MGNoNo

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 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAM OXALATEAmerican Health Packaging3019a647-9bcf-48cf-928c-0467f9b921a82025-03-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsb29ae169-d60b-464a-9763-f1d8d9e0598d2025-01-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepack86cfcd96-6397-42ef-8a79-f62706f0aca62024-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEQuallent Pharmaceuticals Health LLCd8e22060-4d06-42bf-a881-caaf65ecc3e32024-10-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals of New York LLC4f941d7a-5abb-4907-a7a1-480245deef872024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals LLC8704d062-fa91-4224-9dec-41664d20ee6b2024-09-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutions76993020-6715-4090-847e-0fdcc5328f312024-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutionsc980262b-31f0-46df-902d-e593e1557fef2024-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATENorthStar RxLLC81840aec-96fd-4af2-bd10-3f38d068f39a2024-07-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram oxalateESCITALOPRAMExelan Pharmaceuticals Inc.8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd22024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram oxalate
Escitalopram OxalateESCITALOPRAM OXALATEMacleods Pharmaceuticals Limited24b43cb4-1a26-44a2-b1d8-a40239eb5c7c2024-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
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
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
brand name: escitalopram oxalate
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 oxalateESCITALOPRAMAphena Pharma Solutions - Tennessee, LLC900b7a2f-23e7-4c78-bd6e-549bbe09883e2021-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram oxalate
escitalopram oxalateESCITALOPRAM OXALATEProficient Rx LPe773030f-d07d-4bb8-9dc9-6f649688346d2020-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
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
9157ORIG2011-05-10