Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Noven Pharmaceuticals, Inc. | Miami, FL, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyAug 24, 2026 · 11 inspections, 2 with FDA action |
Recalls
- Oct 31, 2024 · Class II · Noven Pharmaceuticals Inc
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Lots: Lot # 95598, Exp 02/28/25
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dextroamphetamine: every company that makes it
- Form
- patch, extended release, transdermal
- Strength
- 13.5 mg
- Approval
- NDA NDA215401
- On the market since
- May 15, 2023
- Package NDCs
68968-0215-168968-0215-3- Official label
- DailyMed (National Library of Medicine), updated Oct 27, 2026
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