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 4 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMAmerican Health Packagingde803217-6d32-4ef8-afe7-02462f37bf0c2025-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopramESCITALOPRAMCoupler LLC2d54a1cf-29cd-c485-e063-6394a90aeba32025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMCoupler LLC2d58c448-4a6c-1b7d-e063-6294a90a7d032025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAMBryant Ranch Prepackd143ec01-9445-42d5-a259-b0b5a7f9445f2025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMBryant Ranch Prepack4966fd83-ee96-4f87-beb1-dd40d70de4452025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsb29ae169-d60b-464a-9763-f1d8d9e0598d2025-01-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMRedPharm Drug, Inc.fc61822a-4058-343c-e053-6294a90af72c2025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMDirect_Rxf6cacd68-0f55-deb9-e053-6294a90aa2662025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMDirect_Rxf75aabf8-f4a1-acd1-e053-6294a90ab9a62025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMAdvanced Rx Pharmacy of Tennessee, LLCf914fec5-4ce7-794d-e053-6294a90a7cc52024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopramESCITALOPRAMBryant Ranch Prepack3ca5da44-403b-4c9f-9dde-f5a87866836d2024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMBryant Ranch Prepack735a138b-fff3-4ed0-8a51-9090cf88ba302024-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepack86cfcd96-6397-42ef-8a79-f62706f0aca62024-10-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEQuallent Pharmaceuticals Health LLCd8e22060-4d06-42bf-a881-caaf65ecc3e32024-10-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals of New York LLC4f941d7a-5abb-4907-a7a1-480245deef872024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals LLC8704d062-fa91-4224-9dec-41664d20ee6b2024-09-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopramESCITALOPRAMRising Pharma Holdings, Inc.ccbe97b5-da68-4fff-929a-240dd705fe6f2024-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAMBryant Ranch Prepack102c3893-4fdc-40b3-bd83-775e292723d72024-08-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMBryant Ranch Prepackc842ec12-8792-47a9-82ad-9edf99e549ba2024-08-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutions76993020-6715-4090-847e-0fdcc5328f312024-07-31Boxed 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
8988ORIG2006-06-06