Elliotts B Solution

Treats meningeal leukemia or lymphocytic lymphoma. NDA 20577, held by Lukare Medical LLC. Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate.

As of Nov 14, 2026, NDA 20577 (Elliotts B Solution), held by Lukare Medical LLC, was first approved by FDA on Sep 27, 1996, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 27, 1996
Review: Priority
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.

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
Sep 27, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Elliotts B Solution0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML · injectable;intrathecal	Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Nov 29, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 17, 2015	Supplement 9Manufacturing · Priority review	Approved	None posted
Jun 11, 2015	Supplement 6Manufacturing · Priority review	Approved	None posted
Jul 18, 2014	Supplement 8Manufacturing · Priority review	Approved	None posted
Dec 14, 2012	Supplement 7Manufacturing · Priority review	Approved	None posted
Nov 17, 2000	Supplement 4Manufacturing · Priority review	Approved	None posted
May 22, 1998	Supplement 2Manufacturing · Priority review	Approved	None posted
May 22, 1998	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 2, 1997	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 27, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20577
Drugs@FDA: Overview at FDA
Company: Lukare Medical

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