FDA.reportPublic FDA data

Application 213864

Type
ANDA
Sponsor
MANKIND PHARMA

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
A213864-001FENOFIBRATEFENOFIBRATE54MGTABLET / ORALAB2020-06-12
A213864-002FENOFIBRATEFENOFIBRATE160MGTABLET / ORALAB2020-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213864-001AB
A213864-002AB

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 22:54:322026-06A213864-001FENOFIBRATE54MGTABLET / ORALAB2020-06-12a50c72e98297…
2026-08-01 22:54:322026-06A213864-002FENOFIBRATE160MGTABLET / ORALAB2020-06-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213864-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213864-002AB1a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.3b6c5ebd-a8bc-4502-8b66-f4e58914815b2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
ndc (product): 70518-2907
FENOFIBRATEFENOFIBRATESt. Mary's Medical Park Pharmacyb92fb19a-d0df-426e-e053-2995a90ab3792026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
ndc (product): 60760-318
FENOFIBRATEFENOFIBRATEA-S Medication Solutionsdf9f67d6-3cd9-4f44-8020-2d6ef53c30b52026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals Inc.e573b3f1-5a4c-4a19-9f0f-ee797b379a082026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
ndc (product): 68788-7816
FENOFIBRATEFENOFIBRATEA-S Medication Solutionsf443dd79-46da-4b02-8188-7417d39cf9752026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.b79efcf4-6016-4a1f-b83f-be00baa25c212026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
ndc (product): 70518-2947
FENOFIBRATEFENOFIBRATENorthwind Health Company, LLCf7590970-c54d-24e9-e053-6294a90ac4002026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATENorthStar RxLLC3b448774-aebf-45fe-92f1-b8eca53cf09b2025-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEMajor Pharmaceuticals3f4e5db8-5bfb-4b24-8465-9757cbaad2be2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATELifestar Pharma LLC1da57e8c-3977-43e1-aa7e-229760203f7d2025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
ndc (product): 70756-215
ndc (product): 70756-214
FENOFIBRATEFENOFIBRATEBryant Ranch Prepackd34f9fa3-39ae-4b8e-8f29-0d5c655c50b52023-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
ndc (product): 71335-1756
FENOFIBRATEFENOFIBRATEProficient Rx LP26f8f793-fb7a-4327-9441-d8737fe1ff112022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
ndc (product): 71205-666

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60760-318FENOFIBRATEFENOFIBRATESt. Mary's Medical Park PharmacyANDACurrent
60760-318FENOFIBRATEFENOFIBRATESt. Mary's Medical Park PharmacyANDACurrent
68071-2540FENOFIBRATEFENOFIBRATENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2540FENOFIBRATEFENOFIBRATENuCare Pharmaceuticals,Inc.ANDACurrent
68788-7816FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7816FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7816FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals Inc.ANDACurrent
70518-2907FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.ANDACurrent
70518-2907FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.ANDACurrent
70518-2947FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.ANDACurrent
70518-2947FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.ANDACurrent
70756-214FENOFIBRATEFENOFIBRATELifestar Pharma LLCANDACurrent
70756-214FENOFIBRATEFENOFIBRATELifestar Pharma LLCANDACurrent
70756-214FENOFIBRATEFENOFIBRATELifestar Pharma LLCANDACurrent
70756-215FENOFIBRATEFENOFIBRATELifestar Pharma LLCANDACurrent
70756-215FENOFIBRATEFENOFIBRATELifestar Pharma LLCANDACurrent
70756-215FENOFIBRATEFENOFIBRATELifestar Pharma LLCANDACurrent
71205-666FENOFIBRATEFENOFIBRATEProficient Rx LPANDACurrent
71335-1756FENOFIBRATEFENOFIBRATEBryant Ranch PrepackANDACurrent