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 3 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
escitalopramESCITALOPRAMTorrent Pharmaceuticals Limited068bb338-23f3-4278-958b-c34b404560242026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAMNorthwind Health Company, LLCf2b3b385-658d-5918-e053-2a95a90afcba2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAM OXALATENorthwind Health Company, LLCf6ca64ec-68ff-e1ea-e053-6294a90ae0f82026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMNorthwind Health Company, LLCd9ba6c65-22bd-10c4-e053-2995a90ada2e2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMNorthwind Health Company, LLCdabf8bc0-5de6-edce-e053-2995a90a73c92026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMNorthwind Health Company, LLCf2b7b0a6-481b-1f6f-e053-2a95a90a2d042026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMNorthwind Health Company, LLCaddccf96-cc60-6045-e053-2a95a90aaac02026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMNorthwind Health Company, LLCc9f52332-8616-19d8-e053-2995a90ad7532026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMNorthwind Health Company, LLCda7feb56-5f5a-7487-e053-2995a90a119e2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMDirect_Rxf81e3858-f01e-1df6-e053-6394a90aef4f2025-12-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAM OXALATEQPharma, Inc.85fbcce8-a870-4f04-8a0e-a12e46eed3cf2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMQPharma, Inc.e56e8d41-188c-5a6f-e053-2a95a90a70e62025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMQPharma, Inc.f682f991-1807-176a-e053-2995a90a3dfa2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopram oxalateESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.b7670e51-8f44-4f64-b110-3f2f431a40322025-10-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMAccord Healthcare Inc.84b2028d-eff4-434d-b71e-6a3c0812f6252025-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopramESCITALOPRAMAlmatica Pharma LLCc0401570-a3b0-bef2-7365-c23dc952b8b62025-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAM OXALATESun Pharmaceutical Industries, Inc.c871d3fe-5ca2-410c-976d-9ec4b72c878f2025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
escitalopramESCITALOPRAMST. MARY'S MEDICAL PARK PHARMACY362327ce-2dde-f657-e063-6394a90a0b632025-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMA-S Medication Solutions3965ca55-a5ff-4ed0-940c-363d74683fab2025-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAM OXALATEAmerican Health Packaging3019a647-9bcf-48cf-928c-0467f9b921a82025-03-21Boxed 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