Tropicamide

ANDA 88447, held by Epic Pharma LLC. Tropicamide.

As of Nov 15, 2026, ANDA 88447 (Tropicamide), held by Epic Pharma LLC, was first approved by FDA on Aug 28, 1985, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 28, 1985
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
Aug 28, 1985	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Nov 29, 1990	Supplement 6Labeling	Approved	None posted
Aug 28, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88447
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