FDA.reportPublic FDA data

Application 079239

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMFIBROZILGEMFIBROZILTABLET;ORAL600MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079239-001GEMFIBROZILGEMFIBROZIL600MGTABLET / ORAL2008-12-29

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A079239-001GEMFIBROZIL600MGTABLET / ORAL2008-12-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079239-001GEMFIBROZIL600MGTABLET / ORAL2008-12-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A079239-001GEMFIBROZIL600MGTABLET / ORAL2008-12-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A079239-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079239-001AB1ea99ee380514…

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GEMFIBROZILGEMFIBROZILREMEDYREPACK INC.42e40524-57e9-4fee-993f-be0fda14936b2026-09-03Warnings, Adverse reactionsName fallback
brand name: GEMFIBROZIL
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILREMEDYREPACK INC.4260d746-bb58-4e10-9ffe-fc414f22b5912026-07-08Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
LopidGEMFIBROZILParke-Davis Div of Pfizer Incc48855b7-215e-453b-b3b1-a0f9dee7221f2026-05-21Warnings, Adverse reactionsName fallback
generic name: GEMFIBROZIL
GEMFIBROZILGEMFIBROZILPreferred Pharmaceuticals, Inc.2f5738ac-1c9c-4f3a-8c7d-6039d768831e2026-05-04Warnings, Adverse reactionsName fallback
brand name: GEMFIBROZIL
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILCoupler LLC509e6e7c-bb54-f135-e063-6294a90a52792026-04-29Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILNorthstar RxLLC75cac02c-56e3-4dfe-b1e2-4ce166b288332026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.bfddc3bd-c2dc-449e-e053-2a95a90a8adc2026-03-05Warnings, Adverse reactionsName fallback
brand name: GEMFIBROZIL
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILNorthwind Health Company, LLCa95264ab-eb86-7699-e053-2995a90a3d1f2026-01-01Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GEMFIBROZILGEMFIBROZILA-S Medication Solutions1967afce-ce55-4b10-bd8c-e4e94130de872025-12-18Warnings, Adverse reactionsName fallback
brand name: GEMFIBROZIL
generic name: GEMFIBROZIL
GEMFIBROZILGEMFIBROZILA-S Medication Solutions929d6a30-ab06-4b43-9147-ab2cc613b41f2025-12-06Warnings, Adverse reactionsName fallback
brand name: GEMFIBROZIL
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILAmerican Health Packaging4e9e08da-9700-4934-a2b1-4f64c70ea8a22025-11-04Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILAvPAK3ebb5947-1fe5-9740-6a4b-1f8b577b27112025-10-29Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILPD-Rx Pharmaceuticals, Inc.5501438d-5247-4f2a-8e15-085276d017252025-09-16Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GEMFIBROZILGEMFIBROZILProficient Rx LPe52c9c88-8197-48b4-88cb-1b4b22ceaf162025-04-01Warnings, Adverse reactionsName fallback
brand name: GEMFIBROZIL
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILNuCare Pharmaceuticals,Inc.592811f2-e231-6a58-e053-2991aa0a69a92024-12-26Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILZydus Pharmaceuticals (USA) Inc.556945e8-4100-4538-bcba-af5b2f13a7e82024-11-08Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILChartwell RX, LLCb8bb442e-66dc-435e-830c-4ba3daa47c042024-10-28Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILA-S Medication Solutions16d0326a-a55b-448b-be24-a16182aaef5a2024-08-30Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GemfibrozilGEMFIBROZILA-S Medication Solutionsefecc680-f626-46bf-bc2b-3b5a72ba02672024-08-30Warnings, Adverse reactionsName fallback
brand name: Gemfibrozil
generic name: GEMFIBROZIL
GEMFIBROZILGEMFIBROZILBryant Ranch Prepackfe98f68c-7182-4a88-93a5-cbdbb37fb8c22024-08-26Warnings, Adverse reactionsName fallback
brand name: GEMFIBROZIL
generic name: GEMFIBROZIL

Reported adverse events (FAERS/openFDA)#

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