Talc

As of Nov 14, 2026, NDA 21388 (Talc), held by Sciarra Labs, was first approved by FDA on Dec 15, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 15, 2003
Review: Priority
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 15, 2003	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Talc5GM/BOT · powder;intrapleural	Talc	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


Jun 13, 2014	Supplement 2Labeling · Standard review	Approved	Letter Label
Dec 15, 2003	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21388
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