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 1 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.9ddd1f24-3ebd-4307-bb23-6acd742cd1402026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.517a551a-6f60-4b8d-9341-63a41baff12d2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEJubilant Cadista Pharmaceuticals Inc.2db02476-325f-ee47-a7e5-b5aed56c364c2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
escitalopramESCITALOPRAMSt. Mary's Medical Park Pharmacy1b2ec266-be5b-9265-e063-6294a90a10e32026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAMBryant Ranch Prepack20281fe6-7db9-4b33-8418-b25e6a5404ca2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAM OXALATEBryant Ranch Prepackee5963ad-3b53-48e5-b7a9-b13af5740ef12026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMBluePoint Laboratoriesd31c02d0-81d9-4aa4-bde9-52135aa5a66d2026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopramESCITALOPRAMBryant Ranch Prepack1d2f83c1-8ffe-48f3-a084-1502890017432026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMBryant Ranch Prepack5c00c4d3-8248-4321-adec-03886c0d0f7b2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
escitalopramESCITALOPRAMREMEDYREPACK INC.76a8aedd-7853-4d3f-9a00-f8222f55bea82026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram
EscitalopramESCITALOPRAM OXALATESt. Mary's Medical Park Pharmacy09945404-e4cf-6269-e063-6294a90a5b8d2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMREMEDYREPACK INC.83fb7392-087d-4284-b27b-fa192e49dc212026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMBryant Ranch Prepack43eb9e4f-1a46-46f7-9e9d-43e866963b372026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
Escitalopram OxalateESCITALOPRAM OXALATECamber Pharmaceuticals, Inc.82d793ee-4039-45fc-ac83-4bd5235f00aa2026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATERising Pharma Holdings, Inc.79fddc2d-2dc2-444f-8fd3-0337090ee7442026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAMREMEDYREPACK INC.b6fbd554-9da7-40fd-87a5-2c4af2aa3e6c2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
EscitalopramESCITALOPRAMREMEDYREPACK INC.83a642b9-acee-45d3-95a1-52a491b770fd2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepacka3a158a3-43ee-4b08-8171-e8c0d6ed0e662026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8988ORIG2006-06-06