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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220518
Company: EUGIA PHARMA

Products on ANDA 220518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220518

MESNA

INJECTABLE;INTRAVENOUS; 100MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	220518	EUGIA PHARMA
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	075811	FRESENIUS KABI USA
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	206992	GLAND
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	075739	HIKMA
MESNA	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090913	SAGENT PHARMS INC
MESNEX	MESNA	100MG/ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	019884	BAXTER HLTHCARE

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