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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219054
Company: FORMOSA LABS

Products on ANDA 219054

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219054

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219054

ERIBULIN MESYLATE

SOLUTION;INTRAVENOUS; 1MG/2ML (0.5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217250	BAXTER HLTHCARE CORP
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218743	CHIA TAI TIANQING
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217473	DR REDDYS
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219054	FORMOSA LABS
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218047	GLAND
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218142	GLENMARK PHARMS INC
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218281	JIANGXI KVVIT PHARM
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214850	LONG GROVE PHARMS
ERIBULIN MESYLATE	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214310	SANDOZ
HALAVEN	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201532	EISAI INC

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