Neurolite

NDA 20256, held by Shine. Technetium Tc-99m Bicisate Kit.

As of Nov 13, 2026, NDA 20256 (Neurolite), held by Shine, was first approved by FDA on Nov 23, 1994, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 23, 1994
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS NEUROLITE single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. NEUROLITE is not indicated for assessment of functional viability of brain tissue. Also, NEUROLITE is not indicated for distinguishing between stroke and other brain lesions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 23, 1994	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
NeuroliteN/A · injectable;injection	Technetium Tc-99m Bicisate Kit	RxReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 3, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
May 18, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 24, 2000	Supplement 7Labeling · Standard review	Approved	None posted
Apr 26, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 30, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
May 15, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 12, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 16, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 12, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 23, 1994	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20256
Drugs@FDA: Overview at FDA
Company: SHINE Medical Technologies

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters