FDA.reportPublic FDA data

Application 200913

Type
ANDA
Sponsor
MYLAN PHARMS INC

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 44.

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
A200913-001FENOFIBRIC ACIDCHOLINE FENOFIBRATEEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25
A200913-002FENOFIBRIC ACIDCHOLINE FENOFIBRATEEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25

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.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A200913-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A200913-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200913-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25e64feba35796…
2022-09-29 23:25 UTC2022-09A200913-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200913-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200913-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A200913-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A200913-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORAL2013-03-25a50c72e98297…

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENOFIBRIC ACIDFENOFIBRIC ACIDLeading Pharma, LLCdaa488be-f580-430c-a72c-80ac31bb3e402025-08-22Warnings, Adverse reactionsName fallback
brand name: FENOFIBRIC ACID
FENOFIBRIC ACIDFENOFIBRIC ACIDAurobindo Pharma Limited9ad201de-fa62-4c49-bc61-ee09b9ba434c2025-08-02Warnings, Adverse reactionsName fallback
brand name: FENOFIBRIC ACID
Fenofibric acidFENOFIBRIC ACIDMacleods Pharmaceuticals Limitedaf225492-73b0-49bb-b32f-5399c3c3ec6d2025-07-03Warnings, Adverse reactionsName fallback
brand name: Fenofibric acid
Fenofibric AcidFENOFIBRIC ACIDAmneal Pharmaceuticals of New York LLCe73404c5-e0ee-48e9-8b09-7a00d7e18e6c2025-06-23Warnings, Adverse reactionsName fallback
brand name: Fenofibric Acid
Fenofibric acidFENOFIBRIC ACIDLupin Pharmaceuticals, Inc.b9a3f97c-9e31-4a5f-822f-c9d45e3944932023-12-08Warnings, Adverse reactionsName fallback
brand name: Fenofibric acid
Fenofibric AcidFENOFIBRIC ACIDAlembic Pharmaceuticals Limitedc880d43a-fa8c-4f7a-a488-419bae7cc3112023-01-30Warnings, Adverse reactionsName fallback
brand name: Fenofibric Acid

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2589Fenofibric Acidfenofibric acidMylan Pharmaceuticals Inc.ANDACurrent
0378-2589Fenofibric Acidfenofibric acidMylan Pharmaceuticals Inc.ANDACurrent
0378-2589Fenofibric Acidfenofibric acidMylan Pharmaceuticals Inc.ANDACurrent
0378-2590Fenofibric Acidfenofibric acidMylan Pharmaceuticals Inc.ANDACurrent
0378-2590Fenofibric Acidfenofibric acidMylan Pharmaceuticals Inc.ANDACurrent
0378-2590Fenofibric Acidfenofibric acidMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32072ORIG2013-03-28