Is there a generic for Iron dextran?

The FDA Orange Book does not currently list an approved generic (ANDA) for Iron dextran. It is available as 4 brand (NDA) applications.

What is the reference-listed drug for Iron dextran?

INFED (NDA 017441, ALLERGAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Iron dextran are approved?

Iron dextran is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iron dextran

Iron dextran is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:INFED · NDA 017441

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
INFEDRLD	ALLERGAN	NDA 017441	BP	Approved Prior to Jan 1, 1982
DEXFERRUM	AM REGENT	NDA 040024	—	Feb 23, 1996
IRON DEXTRAN	SANOFI AVENTIS US	NDA 010787	—	Approved Prior to Jan 1, 1982
PROFERDEX	NEW RIVER	NDA 017807	—	Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Iron dextran — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo