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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

FOSTAMATINIB DISODIUM

ANDA

Tentative Approval

FOSTAMATINIB DISODIUM | A217329 | ANNORA PHARMA

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
RIGEL PHARMACEUTICALS, INC. v. ANNORA PHARMA PRIVATE LTD. et al 2:2022cv04732 5 patentsANDA 217329fostamatinib disodium hexahydrate	D.N.J.	2022-07-25	Terminated 2025-03-26	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

HETERO LABS LTDFOSTAMATINIB DISODIUM HEXAHYDRATE

DMF 366292022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — EQ 100MG BASE

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TABLET;ORAL | Approved: 2026-06-17 00:00:00

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE

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TABLET;ORAL | Approved: 2026-06-17 00:00:00