FDA.reportPublic FDA data

Application 209499

Type
ANDA
Sponsor
DR REDDYS

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
A209499-001ICOSAPENT ETHYLICOSAPENT ETHYL1GMCAPSULE / ORALAB2020-08-07
A209499-002ICOSAPENT 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
A209499-001AB
A209499-002AB

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 22:54:322026-06A209499-001ICOSAPENT ETHYL1GMCAPSULE / ORALAB2020-08-07a50c72e98297…
2026-08-01 22:54:322026-06A209499-002ICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-03-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209499-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209499-002AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icosapent EthylICOSAPENT ETHYLDr. Reddy's Laboratories, Inc.cdcee03e-5df1-a8fc-7490-dfdc624ce6d62026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209499
application number: ANDA209499
IcosapentICOSAPENT ETHYLDr. Reddy's Laboratories, Inc.1aca884c-c464-900d-ac06-33aee7118df82026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209499
application number: ANDA209499
ndc (product): 43598-267
IcosapentICOSAPENT ETHYLBryant Ranch Prepackcc28828d-beab-45cc-a3b6-151c5fee39242024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209499
application number: ANDA209499
ndc (product): 63629-9312

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
43598-267IcosapentIcosapent EthylDr. Reddy's Laboratories, Inc.ANDACurrent
43598-267IcosapentIcosapent EthylDr. Reddy's Laboratories, Inc.ANDACurrent
63629-9312IcosapentIcosapent EthylBryant Ranch PrepackANDACurrent
63629-9312IcosapentIcosapent EthylBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71964ORIG2022-08-30