Levulan

Treats minimally. NDA 20965, held by Sun Pharm Inds Inc. Aminolevulinic Acid Hydrochloride.

As of Nov 13, 2026, NDA 20965 (Levulan), held by Sun Pharm Inds Inc, was first approved by FDA on Dec 3, 1999, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1999
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Mar 6, 2018	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 12, 2010	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 3, 1999	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levulan20% · solution;topical	Aminolevulinic Acid Hydrochloride	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


May 9, 2022	Supplement 17Labeling · Standard review	Approved	Label Letter
Apr 19, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Mar 6, 2018	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 7, 2016	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 14, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 12, 2010	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 17, 2009	Supplement 6Labeling · Standard review	Approved	Letter Label
Jul 11, 2003	Supplement 4Manufacturing · Standard review	Approved	Letter
Jun 27, 2003	Supplement 3Labeling · Standard review	Approved	Label Letter
Mar 26, 2003	Supplement 2Labeling · Standard review	Approved	Letter Label
Jul 27, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 3, 1999	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 20965
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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