FDA.reportPublic FDA data

Application 209457

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ICOSAPENT ETHYLICOSAPENT ETHYLCAPSULE;ORAL1GMNoNo
002ICOSAPENT ETHYLICOSAPENT ETHYLCAPSULE;ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209457-001ICOSAPENT ETHYLICOSAPENT ETHYL1GMCAPSULE / ORALAB2020-05-21
A209457-002ICOSAPENT ETHYLICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209457-001AB
A209457-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209457-001ICOSAPENT ETHYL1GMCAPSULE / ORALAB2020-05-21a50c72e98297…
2026-08-01 22:54:322026-06A209457-002ICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-03-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209457-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209457-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icosapent EthylICOSAPENT ETHYLNorthstar Rx LLC45f8bb41-bdb1-4afc-83ec-9dc69720ee9c2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
ndc (product): 72603-129
Icosapent EthylICOSAPENT ETHYLHikma Pharmaceuticals USA Inc.e3d38d1d-fbe7-413d-849a-675e7dfa9b0a2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
ndc (product): 0054-0508
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack07631e74-48e5-46ec-b8db-4b1bcf62d2832026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack582638e5-9881-409d-a455-041b5ba6892a2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepackf9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c2024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209457
application number: ANDA209457
ndc (product): 63629-9311

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0508Icosapent EthylIcosapent EthylHikma Pharmaceuticals USA Inc.ANDACurrent
63629-9311Icosapent EthylIcosapent EthylBryant Ranch PrepackANDACurrent
63629-9311Icosapent EthylIcosapent EthylBryant Ranch PrepackANDACurrent
72603-129Icosapent EthylIcosapent EthylNorthstar Rx LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63418ORIG2020-06-04