Application 076635

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL54MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL107MGNoNo
003FENOFIBRATEFENOFIBRATETABLET;ORAL160MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076635-001FENOFIBRATEFENOFIBRATE54MGTABLET / ORAL2005-10-31
A076635-002FENOFIBRATEFENOFIBRATE107MGTABLET / ORAL2005-10-31
A076635-003FENOFIBRATEFENOFIBRATE160MGTABLET / ORAL2005-10-31

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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-3184e616aacf4f…
2026-09-14 22:38:342026-08A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-3184e616aacf4f…
2026-09-14 22:38:342026-08A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-3184e616aacf4f…
2026-08-18 06:07:402026-07A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076635-001FENOFIBRATE54MGTABLET / ORAL2005-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076635-003FENOFIBRATE160MGTABLET / ORAL2005-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076635-001FENOFIBRATE54MGTABLET / ORALAB2005-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076635-003FENOFIBRATE160MGTABLET / ORALAB2005-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076635-001FENOFIBRATE54MGTABLET / ORALAB2005-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076635-003FENOFIBRATE160MGTABLET / ORALAB2005-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076635-001FENOFIBRATE54MGTABLET / ORALAB2005-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A076635-003FENOFIBRATE160MGTABLET / ORALAB2005-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076635-001FENOFIBRATE54MGTABLET / ORALAB2005-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076635-002FENOFIBRATE107MGTABLET / ORAL2005-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076635-003FENOFIBRATE160MGTABLET / ORALAB2005-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076635-001FENOFIBRATE54MGTABLET / ORALAB2005-10-31301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076635-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076635-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076635-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076635-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076635-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076635-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076635-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076635-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076635-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076635-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076635-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076635-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076635-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076635-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076635-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076635-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076635-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076635-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076635-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076635-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076635-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076635-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076635-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076635-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076635-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076635-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076635-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076635-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076635-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076635-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076635-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076635-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076635-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076635-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076635-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076635-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076635-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076635-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076635-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076635-003AB1ea99ee380514…

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 4 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FenofibrateFENOFIBRATEAjanta Pharma USA Inc.da2f0ba4-7c16-4fb0-bc1c-45540e8fefbf2025-10-01Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEAmerican Health Packagingd1f64796-6ba0-415c-a6a0-5456b21a7ed62025-10-01Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.24790a18-0291-4b88-a724-acac43b616ce2025-10-01Warnings, Adverse reactionsName fallback
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEBryant Ranch Prepackba8e809e-f6b5-4ba8-9108-81cc82b142252025-09-25Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEBryant Ranch Prepack8eee54d1-48ca-4704-93f3-0ac6fd7f464e2025-09-18Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEBryant Ranch Prepack40ca5d88-6403-4c4b-ae7f-ae8cec4d99652025-09-17Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEQUALLENT PHARMACEUTICALS HEALTH LLC215a5000-9f89-47d9-b2d5-94e13f5e17672025-09-15Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEMylan Pharmaceuticals Inc.5b67f389-55e8-466b-82bd-5ea992f630aa2025-09-15Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATENorthStar RxLLC3b448774-aebf-45fe-92f1-b8eca53cf09b2025-09-13Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEMylan Pharmaceuticals Inc.0f958942-1504-40a1-8ad8-43df2c3f717e2025-08-15Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATETrifluent Pharma LLC3c3539e4-bc4a-8152-e063-6294a90ab55c2025-08-12Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEPreferred Pharmaceuticals Inc.2e6711e9-782d-46bd-9447-6612fe7d0fe72025-08-08Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEAurobindo Pharma Limited84fcea7a-05ed-44c2-98fa-7e87b28d22612025-07-28Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEANI Pharmaceuticals, Inc.c740f57c-cac5-4526-a5a9-aaab65b1caf62025-07-28Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEMylan Institutional Inc.5a90e0a4-7892-462f-9776-037d23a93b102025-07-25Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATECamber Pharmaceuticals, Inc.38f43148-4ca0-402a-ba39-8ee5011a79072025-07-16Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATEAlembic Pharmaceuticals Inc.5c579378-e00e-4802-b9d3-c062cf8bd9f42025-07-15Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEMacleods Pharmaceuticals Limitede8b9d1f5-0541-424f-b1d4-bef6381aa9342025-07-09Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEAmneal Pharmaceuticals NY LLC283e754e-6ffa-4d6a-882f-9bbb3cbc8ca82025-06-25Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEA-S Medication Solutions556c4800-24f6-4237-8636-3211997cbb032025-06-10Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE

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 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-162FenofibrateFenofibrateNORTHSTAR RXLLCANDACurrent
16714-163FenofibrateFenofibrateNORTHSTAR RXLLCANDACurrent
16714-163FenofibrateFenofibrateNORTHSTAR RXLLCANDACurrent
43353-001FenofibrateFenofibrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-1275FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-1275FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-3255FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
51655-901FENOFIBRATEFENOFIBRATENorthwind Pharmaceuticals, LLCANDACurrent
60687-655FenofibrateFenofibrateAmerican Health PackagingANDACurrent
60687-666FenofibrateFenofibrateAmerican Health PackagingANDACurrent
61919-831FENOFIBRATEFENOFIBRATEDirectRXANDACurrent
63187-640FenofibrateFenofibrateProficient Rx LPANDACurrent
63187-640FenofibrateFenofibrateProficient Rx LPANDACurrent
63187-760FenofibrateFenofibrateProficient Rx LPANDACurrent
63187-760FenofibrateFenofibrateProficient Rx LPANDACurrent
63304-900FenofibrateFenofibrateSun Pharmaceutical Industries, Inc.ANDACurrent
63304-900FenofibrateFenofibrateSun Pharmaceutical IndustANDACurrent
63304-900FenofibrateFenofibrateSun Pharmaceutical Industries, Inc.ANDACurrent
63304-900FenofibrateFenofibrateSun Pharmaceutical Industries, Inc.ANDACurrent
63304-901FenofibrateFenofibrateSun Pharmaceutical Industries, Inc.ANDACurrent
63304-901FenofibrateFenofibrateSun Pharmaceutical IndustANDACurrent
63304-901FenofibrateFenofibrateSun Pharmaceutical Industries, Inc.ANDACurrent
63304-901FenofibrateFenofibrateSun Pharmaceutical Industries, Inc.ANDACurrent
63629-1099FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1099FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1099FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1099FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1099FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1100FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1100FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1100FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1100FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1101FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1101FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1101FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1101FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1101FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1514FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1514FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1514FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-1514FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-2505FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-2505FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-6692FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
63629-6692FenofibrateFenofibrateBryant Ranch PrepackANDACurrent
68071-1601FenofibrateFenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1601FenofibrateFenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2135FenofibrateFenofibrateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3300FenofibrateFenofibrateNuCare Pharmaceuticals, Inc.ANDACurrent
68788-7000FenofibrateFenofibratePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31146ORIG2005-11-01