FDA.reportPublic FDA data

Application 090924

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUTILIDE FUMARATEIBUTILIDE FUMARATEINJECTABLE;INJECTION0.1MG/MLNoNo

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
A090924-001IBUTILIDE FUMARATEIBUTILIDE FUMARATE0.1MG/MLINJECTABLE / INJECTION2010-01-11

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 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 UTC2022-10A090924-001IBUTILIDE FUMARATE0.1MG/MLINJECTABLE / INJECTION2010-01-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090924-001IBUTILIDE FUMARATE0.1MG/MLINJECTABLE / INJECTION2010-01-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090924-001IBUTILIDE FUMARATE0.1MG/MLINJECTABLE / INJECTION2010-01-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090924-001IBUTILIDE FUMARATE0.1MG/MLINJECTABLE / INJECTION2010-01-11a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibutilide FumarateIBUTILIDE FUMARATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd02025-11-04Warnings, Adverse reactionsName fallback
brand name: Ibutilide Fumarate
generic name: IBUTILIDE FUMARATE
CorvertIBUTILIDE FUMARATEPharmacia & Upjohn Company LLC2428969a-7431-4e94-9503-ad5c680e2ea42024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUTILIDE FUMARATE
CorvertIBUTILIDE FUMARATEPharmacia & Upjohn Company LLCb7d717ed-022d-4459-b5e6-098c2a8b74272024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUTILIDE FUMARATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31505ORIG2010-01-15