FDA.reportPublic FDA data

Application 201790

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBEEZETIMIBETABLET;ORAL10MGNoNo

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

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
A201790-001EZETIMIBEEZETIMIBE10MGTABLET / ORAL2019-04-26

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A201790-001EZETIMIBE10MGTABLET / ORAL2019-04-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201790-001EZETIMIBE10MGTABLET / ORAL2019-04-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201790-001EZETIMIBE10MGTABLET / ORAL2019-04-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201790-001EZETIMIBE10MGTABLET / ORAL2019-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A201790-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A201790-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201790-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201790-001AB1ea99ee380514…

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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EzetimibeEZETIMIBEA-S Medication Solutions090776cf-f211-49a3-a993-ff5d707311f22026-07-06Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBEA-S Medication Solutionsa1cc2018-72a3-48bc-90de-c460f224cf5a2026-07-06Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBEMajor Pharmaceuticalse257ed7f-5015-4f1d-93f4-5adf5797643d2026-05-21Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EZETIMIBEEZETIMIBEBryant Ranch Prepack02b00cb2-7253-4fb4-a216-53691a929a282026-02-17Warnings, Adverse reactionsName fallback
brand name: EZETIMIBE
generic name: EZETIMIBE
EzetimibeEZETIMIBEAvPAK6fcbfbd9-6e09-8224-e053-2a91aa0a82262026-01-13Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
ZetiaEZETIMIBEOrganon LLC174e45e0-45bb-48b7-9e60-8f6cfc1d22bb2025-11-25Warnings, Adverse reactionsName fallback
generic name: EZETIMIBE
EzetimibeEZETIMIBEMarlex Pharmaceuticals, Inc.109a22f4-a7cb-96c6-e063-6394a90ad7f62025-11-07Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EZETIMIBEEZETIMIBEAccord Healthcare Inc.ceecdbe9-5404-4a93-a488-9211cd1030582025-10-14Warnings, Adverse reactionsName fallback
brand name: EZETIMIBE
generic name: EZETIMIBE
EzetimibeEZETIMIBEAmerican Health Packaging0e9a9eda-1b2a-4475-8483-0f410a17c5242025-10-14Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EZETIMIBEEZETIMIBEA-S Medication Solutions4cfda5aa-e21a-47b2-b296-88d8336298ef2025-10-14Warnings, Adverse reactionsName fallback
brand name: EZETIMIBE
generic name: EZETIMIBE
EZETIMIBEEZETIMIBEA-S Medication Solutions4158aa71-3540-4912-b909-7491e5a1429c2025-10-14Warnings, Adverse reactionsName fallback
brand name: EZETIMIBE
generic name: EZETIMIBE
EzetimibeEZETIMIBEA-S Medication Solutionsdd8a09cb-f014-4650-9da2-4ad1581c97412025-10-10Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBEBryant Ranch Prepackc92292f5-5444-4247-927e-db7bf68161092025-07-17Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBEAscend Laboratories, LLC206d702c-b09a-4555-972b-6555d6d6d6e62025-06-13Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBEBryant Ranch Prepack3a80b668-51cd-42be-8497-8712b05084222025-05-12Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBEAurobindo Pharma Limited726b1e63-437a-4b3b-b773-3ac47a5c0f382025-03-13Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBENorthStar Rx LLC5f5644a9-e019-4e5d-ab6f-3d30b1024c5a2025-03-13Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBEProficient Rx LP55b18d8f-40e0-48ba-baf1-79a0d1bb2ee22025-03-01Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
EzetimibeEZETIMIBEAmneal Pharmaceuticals NY LLC3fadf4e9-017d-4ccd-91dc-a89b981eb1382025-02-10Warnings, Adverse reactionsName fallback
brand name: Ezetimibe
generic name: EZETIMIBE
ezetimibeEZETIMIBEZydus Lifesciences Limitedde814dcd-4759-4e9c-a650-335fb885a79d2024-11-28Name fallback
brand name: ezetimibe
generic name: EZETIMIBE

Reported adverse events (FAERS/openFDA)#

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