Is there a generic for Technetium tc-99m medronate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Technetium tc-99m medronate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Technetium tc-99m medronate?

DRAXIMAGE MDP-25 (NDA 018035, JUBILANT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Technetium tc-99m medronate are approved?

Technetium tc-99m medronate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Technetium tc-99m medronate

Technetium tc-99m medronate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DRAXIMAGE MDP-25 · NDA 018035

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DRAXIMAGE MDP-25RLD×2	JUBILANT	NDA 018035	—	Feb 27, 2004

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.

Technetium tc-99m medronate — frequently asked questions

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

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