Is there a generic for Rose bengal sodium i-131?

The FDA Orange Book does not currently list an approved generic (ANDA) for Rose bengal sodium i-131. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Rose bengal sodium i-131?

ROBENGATOPE (NDA 016224, BRACCO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Rose bengal sodium i-131 are approved?

Rose bengal sodium i-131 is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Rose bengal sodium i-131

Rose bengal sodium i-131 is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ROBENGATOPE · NDA 016224

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ROBENGATOPE×3	BRACCO	NDA 016224	—	Approved Prior to Jan 1, 1982
SODIUM ROSE BENGAL I 131	SORIN	NDA 017318	—	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.

Rose bengal sodium i-131 — frequently asked questions

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

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