FDA.reportPublic FDA data

Application 209950

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL54MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL160MGNoNo

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
A209950-001FENOFIBRATEFENOFIBRATE54MGTABLET / ORALAB2018-03-19
A209950-002FENOFIBRATEFENOFIBRATE160MGTABLET / ORALAB2018-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209950-001AB
A209950-002AB

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 22:54:322026-06A209950-001FENOFIBRATE54MGTABLET / ORALAB2018-03-19a50c72e98297…
2026-08-01 22:54:322026-06A209950-002FENOFIBRATE160MGTABLET / ORALAB2018-03-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209950-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209950-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FenofibrateFENOFIBRATEAmneal Pharmaceuticals NY LLC7e79d495-5d59-485e-b3c2-7c31ba0449482021-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209950
application number: ANDA209950
ndc (product): 69238-1262
ndc (product): 69238-1263

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals LLCANDACurrent
69238-1262FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals LLCANDACurrent
69238-1263FenofibrateFenofibrateAmneal Pharmaceuticals NY LLCANDACurrent