Scopolamine

ANDA 212342, held by Riconpharma LLC. Scopolamine.

As of Nov 13, 2026, ANDA 212342 (Scopolamine), held by Riconpharma LLC, was first approved by FDA on Nov 24, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 24, 2020
Review: Standard
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 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
Nov 24, 2020	Original application	Approved	None posted

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 7Labeling · Standard review	Approved	None posted
Feb 9, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Feb 9, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Nov 24, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 212342
Drugs@FDA: Overview at FDA
Company: Riconpharma LLC

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