Tropicacyl

ANDA 40314, held by Epic Pharma LLC. Tropicamide.

As of Nov 15, 2026, ANDA 40314 (Tropicacyl), held by Epic Pharma LLC, was first approved by FDA on Sep 29, 2000, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 29, 2000
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 29, 2000	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tropicacyl0.5% · solution/drops;ophthalmic	Tropicamide	Rx

All 3 submissions, including labeling and manufacturing supplements


Jul 25, 2012	Supplement 2Labeling	Approved	None posted
Jun 29, 2001	Supplement 1Manufacturing	Approved	None posted
Sep 29, 2000	Original application	Approved	None posted

Identifiers

Application: ANDA 40314
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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