FDA.reportPublic FDA data

Application 078219

Type
ANDA
Sponsor
CARACO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET; ORAL5MGNoNo
002ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET; ORAL10MGNoNo
003ESCITALOPRAM OXALATEESCITALOPRAM 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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Escitalopram OxalateESCITALOPRAMREMEDYREPACK INC.4508226c-5623-41d3-8916-5f94ffdb88392026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
EscitalopramESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.517a551a-6f60-4b8d-9341-63a41baff12d2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEJubilant Cadista Pharmaceuticals Inc.2db02476-325f-ee47-a7e5-b5aed56c364c2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEBryant Ranch Prepackee5963ad-3b53-48e5-b7a9-b13af5740ef12026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATESt. Mary's Medical Park Pharmacy09945404-e4cf-6269-e063-6294a90a5b8d2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATECamber Pharmaceuticals, Inc.82d793ee-4039-45fc-ac83-4bd5235f00aa2026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATERising Pharma Holdings, Inc.79fddc2d-2dc2-444f-8fd3-0337090ee7442026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepacka3a158a3-43ee-4b08-8171-e8c0d6ed0e662026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEAurobindo Pharma Limitedd5fbc8ce-bd41-4bd0-b413-0dea97e596c32026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAM OXALATEAurobindo Pharma Limitedba60c357-8e61-4a3d-b1dc-25602dbbfc2a2026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEPreferred Pharmaceuticals Inc.7d924d16-8a10-411d-be57-97c450f56de72026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAMLegacy Pharmaceutical Packaging, LLC9c68f89b-1d34-4735-9631-817f012935d72026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
EscitalopramESCITALOPRAM OXALATEAsclemed USA, Inc.2957a003-7714-4e16-aeca-623fd6c5d7022026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATENorthwind Health Company, LLCf6ca64ec-68ff-e1ea-e053-6294a90ae0f82026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATEQPharma, Inc.85fbcce8-a870-4f04-8a0e-a12e46eed3cf2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
escitalopram oxalateESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.b7670e51-8f44-4f64-b110-3f2f431a40322025-10-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: escitalopram oxalate
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAMCipla USA Inc.31ce0b82-58fe-44f3-8887-c55d8df1b7732025-10-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate
ESCITALOPRAM OXALATEESCITALOPRAMAscent Pharmaceuticals, Inc1285841d-d9f8-49c6-9456-bf51c8e372712025-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESCITALOPRAM OXALATE
EscitalopramESCITALOPRAM OXALATESun Pharmaceutical Industries, Inc.c871d3fe-5ca2-410c-976d-9ec4b72c878f2025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESCITALOPRAM OXALATE
Escitalopram OxalateESCITALOPRAMAmneal Pharmaceuticals LLC09894a38-4e3a-475d-96cd-c6c8ed87869a2025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Escitalopram Oxalate

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9132ORIG2011-05-10