Scopolamine

ANDA 203753, held by Mylan Technologies. Scopolamine.

As of Nov 13, 2026, ANDA 203753 (Scopolamine), held by Mylan Technologies, was first approved by FDA on Jun 19, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 19, 2019
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Scopolamine transdermal system is indicated in adults for the prevention of:

nausea and vomiting associated with motion sickness.
post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 19, 2019	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Scopolamine1MG/72HR · system;transdermal	Scopolamine	Rx

All 3 submissions, including labeling and manufacturing supplements


Aug 10, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Aug 10, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Jun 19, 2019	Original application	Approved	Review

Identifiers

Application: ANDA 203753
Drugs@FDA: Overview at FDA
Company: Mylan Technologies

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