FDA.reportPublic FDA data

Application 208705

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRIC ACIDCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACIDNoNo
002FENOFIBRIC ACIDCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACIDNoNo

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
A208705-001FENOFIBRIC ACIDCHOLINE FENOFIBRATEEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12
A208705-002FENOFIBRIC ACIDCHOLINE FENOFIBRATEEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208705-001AB
A208705-002AB

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 22:54:322026-06A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12a50c72e98297…
2026-08-01 22:54:322026-06A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208705-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208705-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fenofibric AcidFENOFIBRIC ACIDAlembic Pharmaceuticals Inc.8ffcb173-095a-4550-84f2-18959ad2aab82025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208705
application number: ANDA208705
ndc (product): 62332-244
ndc (product): 62332-245
Fenofibric AcidFENOFIBRIC ACIDAlembic Pharmaceuticals Limitedc880d43a-fa8c-4f7a-a488-419bae7cc3112023-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208705
application number: ANDA208705
ndc (product): 46708-244
ndc (product): 46708-245

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-244Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals LimitedANDACurrent
46708-244Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals LimitedANDACurrent
46708-245Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals LimitedANDACurrent
46708-245Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals LimitedANDACurrent
62332-244Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-244Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-244Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-244Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-244Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-245Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-245Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-245Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-245Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent
62332-245Fenofibric AcidFenofibric AcidAlembic Pharmaceuticals Inc.ANDACurrent