Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217329
Company: ANNORA PHARMA

Products on ANDA 217329

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSTAMATINIB DISODIUM	FOSTAMATINIB DISODIUM	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No
FOSTAMATINIB DISODIUM	FOSTAMATINIB DISODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217329

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217329

FOSTAMATINIB DISODIUM

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSTAMATINIB DISODIUM	FOSTAMATINIB DISODIUM	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	217329	ANNORA PHARMA
TAVALISSE	FOSTAMATINIB DISODIUM	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	209299	RIGEL PHARMS

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSTAMATINIB DISODIUM	FOSTAMATINIB DISODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	217329	ANNORA PHARMA
TAVALISSE	FOSTAMATINIB DISODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	Yes	AB	209299	RIGEL PHARMS