FDA.reportPublic FDA data

Application 076981

Type
ANDA
Sponsor
ALPHAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAMESCITALOPRAM OXALATETABLET; ORAL5MGNoNo
002ESCITALOPRAMESCITALOPRAM OXALATETABLET; ORAL10MGNoNo
003ESCITALOPRAMESCITALOPRAM 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 5 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutionsc980262b-31f0-46df-902d-e593e1557fef2024-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMNuCare Pharmaceuticals, Inc.4a645652-ae1f-3811-e054-00144ff8d46c2024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMNuCare Pharmaceuticals,Inc.a489600b-6ae0-edb7-e053-2a95a90a7d002024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
Escitalopram OxalateESCITALOPRAM OXALATENorthStar RxLLC81840aec-96fd-4af2-bd10-3f38d068f39a2024-07-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMNuCare Pharmaceuticals,Inc.8e88bc86-d5e2-50ca-e053-2995a90a0f0e2024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopramESCITALOPRAMMacleods Pharmaceuticals Limited4d5c3142-b850-49b9-9f5c-81fe15ea7bfb2024-05-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
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
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMA-S Medication Solutions2ffc6ec3-830f-46bc-9b3f-7c42cefa39b22024-04-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAM OXALATEAdvanced Rx Pharmacy of Tennessee, LLC138f8703-2f13-6d07-e063-6394a90a44132024-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITSLOPRAMLupin Pharmaceuticals, Inc.41f7392a-1f5c-4542-9c5c-f9e1098513812023-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMA-S Medication Solutions575d7755-0518-4d48-bb1a-4ad01321fde72023-12-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMA-S Medication Solutions9b0b3c54-5bbc-4db9-9c69-00dac1347f242023-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsac9ede0c-7912-4e7d-83b3-964feee612152023-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutions10b25a10-c5e7-479b-a9f5-7eeafd8023232023-04-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEProficient Rx LP8201a719-7837-45fb-b991-4fcdbf006d242023-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMProficient Rx LP3e3de8ea-b96b-456b-9336-69380fd2d0582023-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMA-S Medication Solutions16a07596-2a89-4897-a829-529452ceb1e82023-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMProficient Rx LP1df5c652-7bad-4b07-b33b-333071bc26702023-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAM OXALATEProficient Rx LP52df055d-b1c8-4de2-8545-ef08b5bf9c392022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
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
8988ORIG2006-06-06