Betadine

NDA 18634, held by Alcon Pharms Ltd. Povidone-Iodine.

As of Nov 13, 2026, NDA 18634 (Betadine), held by Alcon Pharms Ltd, was first approved by FDA on Dec 17, 1986, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1986
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 17, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Betadine5% · solution/drops;ophthalmic	Povidone-Iodine	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Aug 26, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
May 21, 2003	Supplement 7Labeling · Standard review	Approved	Letter
Feb 7, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 30, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 30, 1991	Supplement 4Labeling	Approved	None posted
Oct 27, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 17, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18634
Drugs@FDA: Overview at FDA
Company: Alcon Pharmaceuticals Ltd

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