Tropicamide

ANDA 87637, held by Miza Pharms USA. Tropicamide.

As of Nov 15, 2026, ANDA 87637 (Tropicamide), held by Miza Pharms USA, was first approved by FDA on Aug 9, 1982, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 9, 1982
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Aug 9, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Feb 9, 2000	Supplement 10Manufacturing	Approved	None posted
Feb 13, 1996	Supplement 9Manufacturing	Approved	None posted
Jun 10, 1992	Supplement 6Manufacturing	Approved	None posted
Jun 10, 1992	Supplement 7Labeling	Approved	None posted
Jun 10, 1992	Supplement 8Manufacturing	Approved	None posted
Oct 31, 1988	Supplement 4Manufacturing	Approved	None posted
Oct 31, 1988	Supplement 5Manufacturing	Approved	None posted
Aug 9, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87637
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