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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217076
Company: MYLAN

Products on ANDA 217076

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FERRIC CARBOXYMALTOSE	FERRIC CARBOXYMALTOSE	1GM IRON/20ML (50MG IRON/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217076

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217076

FERRIC CARBOXYMALTOSE

SOLUTION;INTRAVENOUS; 1GM IRON/20ML (50MG IRON/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FERRIC CARBOXYMALTOSE	FERRIC CARBOXYMALTOSE	1GM IRON/20ML (50MG IRON/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217076	MYLAN
INJECTAFER	FERRIC CARBOXYMALTOSE	1GM IRON/20ML (50MG IRON/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	203565	AM REGENT

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