Tropicamide

ANDA 87636, held by Miza Pharms USA. Tropicamide.

As of Nov 15, 2026, ANDA 87636 (Tropicamide), held by Miza Pharms USA, was first approved by FDA on Jul 30, 1982, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1982
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 30, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tropicamide0.5% · solution/drops;ophthalmic	Tropicamide	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Feb 9, 2000	Supplement 9Manufacturing	Approved	None posted
Feb 13, 1996	Supplement 8Manufacturing	Approved	None posted
Jun 10, 1992	Supplement 5Manufacturing	Approved	None posted
Jun 10, 1992	Supplement 6Labeling	Approved	None posted
Jun 10, 1992	Supplement 7Manufacturing	Approved	None posted
Oct 31, 1988	Supplement 3Manufacturing	Approved	None posted
Oct 31, 1988	Supplement 4Manufacturing	Approved	None posted
Jan 3, 1984	Supplement 2Manufacturing	Approved	None posted
Jul 30, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87636
Drugs@FDA: Overview at FDA
Company: Miza Pharms USA

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