Sclerosol

NDA 20587, held by Sciarra Labs. Talc.

As of Nov 13, 2026, NDA 20587 (Sclerosol), held by Sciarra Labs, was first approved by FDA on Dec 24, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1997
Review: Priority
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 24, 1997	Original applicationNew molecular entity · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sclerosol4GM/SPRAY · aerosol;intrapleural	Talc	RxReference drug

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 18, 2012	Supplement 6Manufacturing · Priority review	Approved	Label
Feb 23, 2001	Supplement 2Manufacturing · Priority review	Approved	None posted
Feb 23, 2001	Supplement 3Manufacturing · Priority review	Approved	None posted
Feb 2, 2000	Supplement 1Labeling · Standard review	Approved	None posted
Dec 24, 1997	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20587
Drugs@FDA: Overview at FDA
Company: Sciarra Labs

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