Mydriacyl

ANDA 84305, held by Sandoz. Tropicamide.

As of Nov 15, 2026, ANDA 84305 (Mydriacyl), held by Sandoz, was first approved by FDA on Dec 6, 1974, with 24 approved supplements and 0 published complete response letters.

First approved: Dec 6, 1974
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Dec 6, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mydriacyl0.5% · solution/drops;ophthalmic	Tropicamide	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Aug 27, 2021	Supplement 38Labeling · Standard review	Approved	None posted
Oct 31, 2003	Supplement 31Labeling	Approved	None posted
Dec 23, 2002	Supplement 30Manufacturing	Approved	None posted
Oct 11, 2000	Supplement 25Manufacturing	Approved	None posted
May 16, 2000	Supplement 22Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 28Manufacturing	Approved	None posted
Apr 7, 2000	Supplement 29Manufacturing	Approved	None posted
May 7, 1999	Supplement 23Manufacturing	Approved	None posted
Apr 21, 1999	Supplement 26Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 24Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 21Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 20Manufacturing	Approved	None posted
Feb 7, 1997	Supplement 13Labeling	Approved	None posted
Jan 22, 1997	Supplement 19Manufacturing	Approved	None posted
Oct 5, 1995	Supplement 18Manufacturing	Approved	None posted
Aug 4, 1995	Supplement 17Manufacturing	Approved	None posted
Sep 14, 1993	Supplement 16Labeling	Approved	None posted
Jun 4, 1993	Supplement 14Manufacturing	Approved	None posted
Jun 4, 1993	Supplement 12Manufacturing	Approved	None posted
Nov 5, 1992	Supplement 15Manufacturing	Approved	None posted
Apr 26, 1989	Supplement 11Manufacturing	Approved	None posted
May 3, 1985	Supplement 8Manufacturing	Approved	None posted
Jan 13, 1984	Supplement 7Manufacturing	Approved	None posted
Feb 12, 1982	Supplement 4Manufacturing	Approved	None posted
Dec 6, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84305
Drugs@FDA: Overview at FDA
Company: Sandoz

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