Scopolamine

ANDA 78830, held by Difgen Pharms. Scopolamine.

As of Nov 13, 2026, ANDA 78830 (Scopolamine), held by Difgen Pharms, was first approved by FDA on Jan 30, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 30, 2015
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Scopolamine transdermal system is indicated in adults for 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. Scopolamine transdermal system is an anticholinergic 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 4 submissions below

Date	Submission	Status	Documents
Jan 30, 2015	Original application	Approved	Review Letter Label

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Feb 9, 2026	Supplement 16Labeling · Standard review	Approved	None posted
Feb 9, 2026	Supplement 21Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Jan 30, 2015	Original application	Approved	Review Letter Label

Identifiers

Application: ANDA 78830
Drugs@FDA: Overview at FDA
Company: Difgen Pharmaceuticals

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