Application 050010

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ILOSONEERYTHROMYCIN ESTOLATESUSPENSION;ORALEQ 125MG BASE/5MLNoNo
002ILOSONEERYTHROMYCIN ESTOLATESUSPENSION;ORALEQ 250MG BASE/5MLNoNo

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

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
N050010-001ILOSONEERYTHROMYCIN ESTOLATEEQ 125MG BASE/5MLSUSPENSION / ORALApproved before 1982
N050010-002ILOSONEERYTHROMYCIN ESTOLATEEQ 250MG BASE/5MLSUSPENSION / ORALApproved before 1982

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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N050010-001ILOSONEEQ 125MG BASE/5MLSUSPENSION / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N050010-002ILOSONEEQ 250MG BASE/5MLSUSPENSION / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050010-001ILOSONEEQ 125MG BASE/5MLSUSPENSION / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050010-002ILOSONEEQ 250MG BASE/5MLSUSPENSION / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050010-001ILOSONEEQ 125MG BASE/5MLSUSPENSION / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050010-002ILOSONEEQ 250MG BASE/5MLSUSPENSION / ORALApproved before 1982a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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