Is there a generic for Gadopentetate dimeglumine?

The FDA Orange Book does not currently list an approved generic (ANDA) for Gadopentetate dimeglumine. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Gadopentetate dimeglumine?

MAGNEVIST (NDA 021037, BAYER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gadopentetate dimeglumine are approved?

Gadopentetate dimeglumine is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Gadopentetate dimeglumine

Gadopentetate dimeglumine is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:MAGNEVIST · NDA 021037

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
MAGNEVISTRLD	BAYER HLTHCARE	NDA 021037	—	Mar 10, 2000
MAGNEVISTRLD	BAYER HLTHCARE	NDA 019596	—	Jun 02, 1988

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.

Gadopentetate dimeglumine — frequently asked questions

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

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