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 2 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMSOLCO HEALTHCARE US, LLC155e973a-f4ff-4e5a-b937-09f1e106fe392026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAM OXALATEAurobindo Pharma Limitedd5fbc8ce-bd41-4bd0-b413-0dea97e596c32026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMPD-Rx Pharmaceuticals, Inc.2d125ea4-5430-5b4e-e054-00144ff88e882026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
Escitalopram OxalateESCITALOPRAM OXALATEAurobindo Pharma Limitedba60c357-8e61-4a3d-b1dc-25602dbbfc2a2026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMCoupler LLC5088d6cd-ec13-384d-e063-6394a90aee052026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopramESCITALOPRAMCardinal Health 107, LLCcb3f9af4-5bb4-48a8-b972-ff92cff1ea012026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.eef1c681-1972-4c3f-b4ba-cbb3388f397a2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAMPreferred Pharmaceuticals, Inc.3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f882026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopram oxalateESCITALOPRAM OXALATEPreferred Pharmaceuticals Inc.7d924d16-8a10-411d-be57-97c450f56de72026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.d16a7510-c787-4c9b-818b-1ffbcc62b3c32026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMBryant Ranch Prepacka0ff752d-cb30-4131-a7d6-cd66d8a47b1a2026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMBryant Ranch Prepackcb30d1c5-2280-465f-84f4-4367ad5f1a312026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMBryant Ranch Prepack0de88dad-d54c-4773-a5d6-a705e012973a2026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAMDirect_Rxf435d670-87ff-f226-e053-2a95a90ac0ee2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopramESCITALOPRAMMajor Pharmaceuticalsf4a12048-181e-45ed-a382-f53096d1b6892026-02-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAMPD-Rx Pharmaceuticals, Inc.83510549-bd47-4969-aba0-c149a0fbb7f32026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopramESCITALOPRAMBryant Ranch Prepack64de12e0-c35f-4082-b902-ddbaee8158a62026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAM OXALATEAsclemed USA, Inc.2957a003-7714-4e16-aeca-623fd6c5d7022026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMA-S Medication Solutionsba6a0c20-4915-4164-a39e-ca67d652cbfd2026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMA-S Medication Solutionsa0344290-6e12-46c4-a11c-5347a770adbe2026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram

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