FDA.reportPublic FDA data

Application 021612

Type
NDA
Sponsor
CIPHER PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIPOFENFENOFIBRATECAPSULE;ORAL50MGYesNo
002LIPOFENFENOFIBRATECAPSULE;ORAL100MGNoNo
003LIPOFENFENOFIBRATECAPSULE;ORAL150MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021612-001LIPOFENFENOFIBRATE50MGCAPSULE / ORALRLD2006-01-11
N021612-002LIPOFENFENOFIBRATE100MGCAPSULE / ORALRLD2006-01-11
N021612-003LIPOFENFENOFIBRATE150MGCAPSULE / ORALRLD, RS2006-01-11

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021612-001LIPOFEN50MGCAPSULE / ORALRLD2006-01-11f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021612-002LIPOFEN100MGCAPSULE / ORAL2006-01-11f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021612-003LIPOFEN150MGCAPSULE / ORALRLD, RS2006-01-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021612-001LIPOFEN50MGCAPSULE / ORALRLD2006-01-11e64feba35796…
2022-09-29 23:25 UTC2022-09N021612-002LIPOFEN100MGCAPSULE / ORAL2006-01-11e64feba35796…
2022-09-29 23:25 UTC2022-09N021612-003LIPOFEN150MGCAPSULE / ORALRLD, RS2006-01-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021612-001LIPOFEN50MGCAPSULE / ORALRLD2006-01-11cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021612-002LIPOFEN100MGCAPSULE / ORAL2006-01-11cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021612-003LIPOFEN150MGCAPSULE / ORALRLD, RS2006-01-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021612-001LIPOFEN50MGCAPSULE / ORALRLD2006-01-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021612-002LIPOFEN100MGCAPSULE / ORALRLD2006-01-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021612-003LIPOFEN150MGCAPSULE / ORALRLD, RS2006-01-11a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LipofenFENOFIBRATEANI Pharmaceuticals, Inc.78b789b9-854f-46b9-97f3-a48759a6ff892026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 021612
application number: NDA021612
ndc (product): 62559-306
ndc (product): 62559-305
FenofibrateFENOFIBRATEANI Pharmaceuticals, Inc.3a69e15a-eda6-4a6e-8934-6881e43705212026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 021612
application number: NDA021612
ndc (product): 62559-461
ndc (product): 62559-460

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61269-210FenofibratefenofibrateH2-Pharma, LLCNDACurrent
61269-212FenofibratefenofibrateH2-Pharma, LLCNDACurrent
62559-305LipofenfenofibrateANI Pharmaceuticals, Inc.NDACurrent
62559-306LipofenfenofibrateANI Pharmaceuticals, Inc.NDACurrent
62559-460FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-460FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-460FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-460FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-461FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-461FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-461FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-461FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
66869-137LIPOFENfenofibrateKowa Pharmaceuticals America Inc.NDACurrent
66869-137LIPOFENfenofibrateKowa Pharmaceuticals America Inc.NDACurrent
66869-137LIPOFENfenofibrateKowa Pharmaceuticals America, Inc.NDACurrent
66869-137LIPOFENfenofibrateKowa Pharmaceuticals America, Inc.NDACurrent
66869-147LIPOFENfenofibrateKowa Pharmaceuticals America Inc.NDACurrent
66869-147LIPOFENfenofibrateKowa Pharmaceuticals America Inc.NDACurrent
66869-147LIPOFENfenofibrateKowa Pharmaceuticals America, Inc.NDACurrent
66869-147LIPOFENfenofibrateKowa Pharmaceuticals America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82500SUPPL 2025-06-09
82489SUPPL 2025-06-09
67720SUPPL2021-06-07
67703SUPPL2021-06-04
58758SUPPL2019-05-16
58746SUPPL2019-05-16
56457SUPPL2018-11-15
56384SUPPL2018-11-08
54280SUPPL2018-05-21
54279SUPPL2018-05-21
37338SUPPL2013-01-23
28246SUPPL2013-01-23
15876SUPPL2013-01-23
5856SUPPL2013-01-23
5855SUPPL2011-11-02
15875SUPPL2011-10-31
28245SUPPL2008-12-19
5854SUPPL2008-12-19
42233ORIG2008-11-17
15874ORIG2006-01-24
5853ORIG2006-01-24