FDA.reportPublic FDA data

Application 212369

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELIGLUSTAT TARTRATEELIGLUSTAT TARTRATECAPSULE;ORALEQ 84MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212369-001ELIGLUSTAT TARTRATEELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORAL2024-12-10

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORAL2024-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORALAB2024-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORALAB2024-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORALAB2024-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORALAB2024-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORALAB2024-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORALAB2024-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORALAB2024-12-102680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212369-001ELIGLUSTAT TARTRATEEQ 84MG BASECAPSULE / ORAL2024-12-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212369-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212369-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212369-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212369-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212369-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212369-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212369-001AB12680178bc6a6…