FDA.reportPublic FDA data

Application 217329

Type
ANDA
Sponsor
ANNORA PHARMA

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

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
A217329-001FOSTAMATINIB DISODIUMFOSTAMATINIB DISODIUMEQ 100MG BASETABLET / ORALAB2026-06-17
A217329-002FOSTAMATINIB DISODIUMFOSTAMATINIB DISODIUMEQ 150MG BASETABLET / ORALAB2026-06-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A217329-001AB
A217329-002AB

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 06:07:402026-07A217329-001FOSTAMATINIB DISODIUMEQ 100MG BASETABLET / ORALAB2026-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A217329-002FOSTAMATINIB DISODIUMEQ 150MG BASETABLET / ORALAB2026-06-17caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217329-001FOSTAMATINIB DISODIUMEQ 100MG BASETABLET / ORALAB2026-06-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217329-002FOSTAMATINIB DISODIUMEQ 150MG BASETABLET / ORALAB2026-06-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217329-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217329-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217329-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217329-002AB1a50c72e98297…