Last Updated: August 10, 2026

Details for New Drug Application (NDA): 217076

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NDA 217076 describes FERRIC CARBOXYMALTOSE, which is a drug marketed by Mylan and Mylan Labs Ltd and is included in three NDAs. It is available from one supplier. Additional details are available on the FERRIC CARBOXYMALTOSE profile page.

The generic ingredient in FERRIC CARBOXYMALTOSE is ferric carboxymaltose. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric carboxymaltose profile page.

Summary for 217076

Tradename:	FERRIC CARBOXYMALTOSE
Applicant:	Mylan
Ingredient:	ferric carboxymaltose
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1GM IRON/20ML (50MG IRON/ML)
Approval Date:	Jun 25, 2026	TE:	AP	RLD:	No

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