Tropicamide

ANDA 89172, held by Alcon Pharms Ltd. Tropicamide.

As of Nov 15, 2026, ANDA 89172 (Tropicamide), held by Alcon Pharms Ltd, was first approved by FDA on Dec 28, 1990, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1990
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 28, 1990	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tropicamide1% · solution/drops;ophthalmic	Tropicamide	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Dec 4, 1996	Supplement 8Manufacturing	Approved	None posted
Apr 16, 1996	Supplement 4Manufacturing	Approved	None posted
Jun 30, 1995	Supplement 3Labeling	Approved	None posted
Aug 21, 1992	Supplement 2Manufacturing	Approved	None posted
Oct 8, 1991	Supplement 1Manufacturing	Approved	None posted
Dec 28, 1990	Original application	Approved	None posted

Identifiers

Application: ANDA 89172
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