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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 017318

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NDA 017318 describes SODIUM ROSE BENGAL I 131, which is a drug marketed by Sorin and is included in one NDA. Additional details are available on the SODIUM ROSE BENGAL I 131 profile page.

The generic ingredient in SODIUM ROSE BENGAL I 131 is rose bengal sodium i-131. There are one hundred and four drug master file entries for this compound. Additional details are available on the rose bengal sodium i-131 profile page.

Summary for 017318

Tradename:	SODIUM ROSE BENGAL I 131
Applicant:	Sorin
Ingredient:	rose bengal sodium i-131
Patents:	0

Medical Subject Heading (MeSH) Categories for 017318

Fluorescent Dyes

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.5mCi/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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