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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218047
Company: GLAND PHARMA LTD

Products on ANDA 218047

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 218047

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218047

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	218047	GLAND PHARMA LTD
HALAVEN	ERIBULIN MESYLATE	1MG/2ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201532	EISAI INC

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