Is there a generic for Ferrous citrate, fe-59?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ferrous citrate, fe-59. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Ferrous citrate, fe-59?

FERROUS CITRATE FE 59 (NDA 016729, MALLINCKRODT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ferrous citrate, fe-59 are approved?

Ferrous citrate, fe-59 is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ferrous citrate, fe-59

Ferrous citrate, fe-59 is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:FERROUS CITRATE FE 59 · NDA 016729

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
FERROUS CITRATE FE 59	MALLINCKRODT	NDA 016729	—	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.

Ferrous citrate, fe-59 — frequently asked questions

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

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